Recall Z-0548-2022 ยท HRS Plate, Fixation, Bone
Smith & Nephew, Inc.
INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
| Date | Jan 4, 2022 |
| Status | Open, Classified |
| Reason | The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw |
| Root cause | Process control |
| Action | The firm initiated the recall by letter and email on 01/04/2022. The letter requested that the consignee examine their inventory, quarantine all affected units, and return the completed response form. Entities who have further distributed the product were directed to notify their customers. The firm is seeking return of the product. |
| Quantity | 8 units (US) |
| Distribution | US Nationwide distribution in the states of CA and OH. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073375 | NEWDEAL TIBIAXYS SYSTEM Newdeal Sas, Feb 21, 2008 |