"***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.
This recall has been terminated (originally issued October 29, 2012).
- Recall Initiated
- April 9, 2012
- Posted
- October 29, 2012
- Terminated
- November 21, 2013
- Recall Number
- Z-0164-2013
- Quantity
- 2 units
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand
Lot / Code Info
Lot # 330889 and Catalog: PFT-00M - No Expiration date
Root Cause
Process control
Action Taken
Linvatec Corp sent a Urgent Medical Device Recall Notification letter dated April 9, 2012, to all affected customers. The letter was sent via FEDEx and by e-mail. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to check their inventory for the recalled product and segregate them for return to the recalling firm. Furthermore, return the products along with the "REPLY FORM". Should you have any further questions please contact our Customer Service department at (800) 237-0169.