Device product
CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
Z-2147-2012
Product summary
- Event
- Event 62395
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2
- Official record key
device-enforcement:Z-2147-2012
Official wording
Reason: ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.
Code information: Lot #156920
Distribution pattern: Nationwide Distribution, including the states of Colorado and Pennsylvania.
Derived failure modes
-
Unknown
ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.