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Open, Classified

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

FDA Recall Z-3171-2024 · Posted 2024-09-19

Recalling FirmSmith & Nephew, Inc.
Recall StatusOpen, Classified
Product CodeHTY
Date Initiated2024-07-09
Product Quantity24 units

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.

Firm 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 [email protected].

Root Cause

Packaging change control

Distribution Pattern

US, Canada, Norway

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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