DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
This recall is currently active, issued September 19, 2024. It was issued by Smith & Nephew Inc.
- Company
- Smith & Nephew Inc
- Recall Initiated
- July 9, 2024
- Posted
- September 19, 2024
- Recall Number
- Z-3171-2024
- Quantity
- 24 units
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US, Canada, Norway
Lot / Code Info
Batch 23GNX0077
Root Cause
Packaging change control
Action Taken
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.