Z-0625-2015Class II

PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended...

Name: Z-0625-2015 PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended...
Creator: Stryker Endoscopy
Published: 2014-11-17
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2014-11-17 / Terminated / root cause: labeling and UDI

FDA source

Stryker Endoscopy began a recall of PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of... on 2014-11-17. FDA classified it as Class II and gives the reason as "The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0625-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-17
Posted: 2014-12-12
Terminated: 2015-07-17
Recalling firm: Stryker Corp.
Product: PKG, AXIAL HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080235. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
Product code: KOG
Reason for recall: The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Stryker Endoscopy sent an Urgent Device Correction letter dated November 17, 2014, to affected customers. The letter informed the customers of the potential hazards and actions required. Customers were instructed to discard any old Instructions for Use for their Laparoscopic Manual Instruments and Accessories. Download the new Instuctions for Use (IFU1000-401-070 Revision J) from the URL link below: www.stryker.com/IFU1000401070 Customers were instructed to complete and sign the enclosed "Acknowledgement of Receipt" form and email them to [email protected] or fax to (408) 855-6314. Customers with questions were instructed to contact Stryker Endoscopy at 408-855-6238 or via email at [email protected]. For questions regarding this recall call 408-754-2000.
Quantity in commerce: 180,573 units total
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
Product codes and lots: 41811 140622 140726 140727 140729 342723 345252 544042 544043 644785 645845 645850 645852 645854 648085 06CON06065 744231 744232 745522 746745 840675 842159 842161 842197 842207 846841 846842 846844 846845 846847 846848 846849 846850 846851 846853 846855 942926 942943 942944 942945 942946 942947 942950 942951 942953 942954 942960 942964 943554 1044584 1044800 1045871 1046151 1046152 1046159 1046162 1046165 1140204 1140205 1140659 1140660 1140662 1142190 1142191 1143092 1143093 1143436 1143437 1144693 1144694 1144696 1145106 1145400 1145478 1146161 1146982 1240188 1240189 1241117 1241949 1242400 1243129 1243584 1243585 1244442 1244882 1246186 1246187 1340352 1340493 1340494 1341007 1341164 1341880 1342685 1342858 1344252 1344707 1440353 1442562 1443626 544043 645847

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0625-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0592-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0593-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0594-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0595-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0596-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0597-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0598-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0599-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0600-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0601-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0602-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0603-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0604-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0605-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0606-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0607-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0608-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0609-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0610-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0611-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0612-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0613-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0614-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0615-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0616-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0617-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0618-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0619-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0620-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0621-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0622-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0623-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0624-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0625-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0626-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0627-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0628-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0629-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0630-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0631-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0632-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0633-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0634-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0635-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0636-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0637-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0638-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0639-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0640-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0641-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0642-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0643-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0644-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0645-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0646-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0647-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0648-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0649-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0650-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0651-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0652-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0653-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0654-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0655-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0656-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0657-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0658-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0659-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0660-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0661-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0662-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0663-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0664-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0665-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0666-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0667-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0668-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0669-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0670-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0671-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0672-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0673-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0674-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0675-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0676-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0677-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0678-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0679-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0680-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0681-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0682-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0683-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0684-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0685-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0686-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0687-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0688-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0689-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0690-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0691-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0692-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0693-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0694-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0695-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0696-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0697-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0698-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0699-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0700-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0701-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0702-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0703-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0704-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0705-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0706-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0707-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0708-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0709-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0710-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0711-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0712-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0713-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0714-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0715-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0716-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0717-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0718-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0719-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0720-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0721-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0722-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0723-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0724-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0725-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0726-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0727-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0728-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0729-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0730-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0731-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0732-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0733-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0734-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0735-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0736-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0737-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0738-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0739-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0740-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0741-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0742-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0743-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0744-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0745-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0746-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0747-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0748-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0749-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0750-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0751-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0752-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0753-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0754-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0755-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0756-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0757-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0758-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0759-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0760-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0761-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0762-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0763-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0764-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0765-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0766-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0767-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0768-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0769-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0770-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0771-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0772-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0773-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0774-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0775-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0776-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0777-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0778-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0779-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0780-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0781-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0782-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0783-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0784-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0785-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0786-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0787-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0788-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0789-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0790-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0791-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

Product code KOG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)