Recall Z-2147-2012 ยท LXH Orthopedic Manual Surgical Instrument
Linvatec Corp. dba ConMed Linvatec
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.
| Date | Aug 6, 2012 (initiated Aug 12, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Use error |
| Action | The firm sent an "URGENT: Medical Device Recall Notification" letter dated August 12, 2011, to its customers after initial phone notifications. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1) Immediately check their facility's inventory for the product number and lot number listed in the letter. If the product is at their facility, they were instructed to discontinue the use of the product. 2) To return the products to ConMed Linvatec for credit and return the products and Reply Form. 3) If the product was transferred to another facilit |
| Quantity | 2 |
| Distribution | Nationwide Distribution, including the states of Colorado and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.