DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Recall
- Recall Number
- Z-3172-2024
- Event Number
- 95154
- Firm
- Smith & Nephew, Inc.
- FEI Number
- 1020279
- Product Code
- HTY
- Status
- Open, Classified
- Root Cause
- Packaging change control
- Initiated
- July 9, 2024
- Posted
- September 19, 2024
- Address
- 1450 E Brooks Rd, Memphis, TN, 38116-1804
Description
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
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.
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 [email protected].
US, Canada, Norway
73 units