Reported Sep 25, 2024 · Ongoing

DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener

Smith & Nephew, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Smith & Nephew, Inc. · 1450 E Brooks Rd · Memphis, TN · 38116-1804

Is this the product you have?

  • DIAMOND POINT, BOTH ENDS K-WIRE, REF 128062, metallic bone fixation fastener
Lot codes and dates
  • Batch 21KNX0074
Amount recalled
73 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:33 PM UTC

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