—#209611

Product

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener

FDA product code: HTY — Pin, Fixation, Smooth
Device class: Class 2
Medical specialty: Orthopedic
Affected lot / code info: Batch 23GNX0077

Why it was recalled

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 (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern: US, Canada, Norway

Timeline

Recall initiated: 2024-07-09
Posted by FDA: 2024-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.