Smith & Nephew, Inc.: Device Recall

Recall #Z-0957-2026 · 11/24/2025

Class II: Risk

Recall Details

Recall Number: Z-0957-2026
Classification: Class II
Product Type: Device
Recalling Firm: Smith & Nephew, Inc.
Status: Ongoing
Date Initiated: 11/24/2025
Location: Mansfield, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 168 units (US 83; OUS 85)

Reason for Recall

Removal of affected lot of screws due to labeling error.

Product Description

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

Distribution Pattern

US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN, NC, NE, NY, OK, TN, TX, UT; OUS (Foreign) to countries of: Australia, Czech Republic, Finland, France, Germany, Indonesia, Italy, Malaysia, Martinique, Mexico, Netherlands, Norway, Poland, Singapore, Switzerland.

Other Recalls by Smith & Nephew, Inc.

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.
Class II: Risk 10/02/2024

Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT 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.