Smith & Nephew, Inc.: Device Recall

Recall #Z-3171-2024 · 07/09/2024

Class II: Risk

Recall Details

Recall Number: Z-3171-2024
Classification: Class II
Product Type: Device
Recalling Firm: Smith & Nephew, Inc.
Status: Ongoing
Date Initiated: 07/09/2024
Location: Memphis, TN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 24 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.

Product Description

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

Distribution Pattern

US, Canada, Norway

Other Recalls by Smith & Nephew, Inc.

Class II: Risk 11/24/2025

Removal of affected lot of screws due to labeling error.
Class II: Risk 03/18/2025

Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw, and exchange may exceed 30 minutes.
Class II: Risk 10/29/2024

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
Class II: Risk 10/15/2024

The Bipolar assembly contains an oversized Retainer Ring.
Class II: Risk 10/02/2024

Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.

View all recalls by Smith & Nephew, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.