Recall Z-0164-2013 ยท LXH Orthopedic Manual Surgical Instrument
Linvatec Corp. dba ConMed Linvatec
"***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.
| Date | Oct 29, 2012 (initiated Apr 9, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 2 units |
| Distribution | Worldwide Distribution--US (nationwide) including state of Minnesota and the country of Thailand |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.