Device product
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
Z-0164-2013
Product summary
- Event
- Event 63090
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 units
- Official record key
device-enforcement:Z-0164-2013
Official wording
Reason: ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
Code information: Lot # 330889 and Catalog: PFT-00M - No Expiration date
Distribution pattern: Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
Derived failure modes
-
Unknown
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.