Recall Z-3172-2024
Smith & Nephew, Inc. · initiated July 9, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Codes / lots: Batch 21KNX0074
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.
FDA-determined 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.
Details
- Recall number
- Z-3172-2024
- Initiated
- July 9, 2024
- Posted by FDA
- September 19, 2024
- Product code
- HTY – Pin, Fixation, Smooth
- Quantity
- 73 units
- Distribution
- US, Canada, Norway
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3171-2024 Class II | DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastenerSmith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a… | 07/09/2024Open, Classified |