Recall Z-3171-2024 ยท HTY Pin, Fixation, Smooth
Smith & Nephew, Inc.
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
| Date | Sep 19, 2024 (initiated Jul 9, 2024) |
| Status | Open, Classified |
| Reason | Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead of K-WIRE .045X9 2PT DM as described on the product label. |
| Root cause | Packaging change control |
| Action | Smith & Nephew issued and Urgent Medical Device Recall Notice to its consignees on 07/09/2024 via overnight mail. The notice explained the problem, potential risk, and requested the return of the product. Sales representatives, District Offices, and/or Distributors were directed to notify their customers. For questions or concerns regarding this recall please contact FieldActions@smith-nephew.com. |
| Quantity | 24 units |
| Distribution | US, Canada, Norway |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.