FDAFDA · Food and drugs·Recall number Z-3171-2024
DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Published September 25, 2024 · Recall initiated: July 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Smith & Nephew, Inc.
- Distributor
- US, Canada, Norway
- Lot
- Batch 23GNX0077
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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