Z-0598-2015Class II

PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are intended for...

Name: Z-0598-2015 PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are intended for...
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, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue... 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-0598-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-17
Posted: 2014-12-12
Terminated: 2015-07-17
Recalling firm: Stryker Corp.
Product: PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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: 542650 744316 746309 746656 840349 845864 940057 940150 940431 942656 944708 945457 1040794 1041288 1043107 1043115 1045071 1046601 1140168 1142891 1143157 1143970 1144494 1144654 1146465 1146836 1147098 1241415 1242117 1242944 1245442 1245450 1340115 1341560 1341562 1343425 1344136 1441095 790382

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0598-2015
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)