Recall Z-1574-2016 ยท HWC Screw, Fixation, Bone
Synthes (USA) Products LLC
5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm Sterile; Catalog ID # 02.221.462S Indicated for fixation of various long bones.
| Date | Apr 4, 2016 |
| Status | Terminated |
| Reason | This lot of the 5.0 mm Periprosthetic Locking Screw, Self-tapping, 12mm Sterile, was shipped after the expiration date of May 31, 2012. The label on the product has the correct expiration date. |
| Root cause | Process control |
| Action | DePuy Synthes mailed to customers an Urgent Notice informing them they were voluntarily recalling 5.0 mm Periprosthetic Locking Screw Self-tapping 12 mm-Sterile, part # 02.221.462S, Lot # 5539094, expiration date May 31, 2012, due to the units being shipped after the expiration date of May 31, 2012. Customers were instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section on page 3 by checking the appropriate box and return the form and product to Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. |
| Quantity | 15 units |
| Distribution | Distributed in IL and IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041533 | SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS Synthes (Usa), Sep 1, 2004 |