Z-0676-2015Class II

PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are intended for cutting, holding...

Name: Z-0676-2015 PKG, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are intended for cutting, holding...
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, DEBANEY FORCEPS, P/N 0250080314. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ... 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-0676-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-17
Posted: 2014-12-12
Terminated: 2015-07-17
Recalling firm: Stryker Corp.
Product: PKG, DEBANEY FORCEPS, P/N 0250080314. 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
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: 143177 143178 246074 344739 444155 644081 645995 647106 647107 647111 647115 647116 647119 647121 647122 647123 647124 647125 647126 846997 940698 940700 940701 940702 940706 940707 940708 940709 940713 940714 940715 940717 940721 940722 940723 940724 943750 943862 1045977 1045978 1045979 1045980 1046707 1141928 1141929 1143434 1143435 1144968 1145466 1145467 1240129 1240549 1242018 1242851 1242852 1243860 1243861 1244476 1244788 1245555 1245556 1245969 1246404 1246406 1340287 1340723 1340724 1342682 1342842 1342843 1342844 1343524 1343525 1343989 1343990 1344458 1346205 1440786 1441077 1441462 1442554 1443205 644082

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0676-2015
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)