Z-0639-2015Class II

PKG, PKG, HOOK SCISSORS, P/N 0250080260. Laparoscopic Manual Instruments are intended for cutting, holding...

Name: Z-0639-2015 PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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, PKG, HOOK SCISSORS, P/N 0250080260. 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-0639-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-17
Posted: 2014-12-12
Terminated: 2015-07-17
Recalling firm: Stryker Corp.
Product: PKG, PKG, HOOK SCISSORS, P/N 0250080260. 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: 41490 44630 140583 142467 142469 143688 144270 246031 440310 443401 443405 443406 443407 542490 542498 542499 641965 641966 641968 645668 741519 741520 741521 741523 744992 744994 744995 747000 747001 747002 841991 842244 842246 842248 842259 842263 842267 842271 842876 941705 942762 942846 943012 943044 943107 943247 943417 943747 944089 944704 944838 944885 945128 945554 945555 945557 945558 945559 945562 945564 945565 945568 945569 1042239 1042474 1044885 1046102 1046734 1046735 1140692 1141608 1142179 1143096 1143097 1144503 1145104 1145105 1146377 1146378 1147161 1147162 1241404 1242145 1242261 1243810 1244133 1244439 1245093 1245235 1245831 1246051 1246185 1340227 1340932 1340933 1341825 1342200 1342201 1342202 1343515 1343516 1345798 1440785 1441076 1442552

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0639-2015
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)