Smith & Nephew, Inc.

13 FDA enforcement actions

13 Total Recalls

0 Class I

13 Class II

0 Class III

Firm Details

Product Types: device
States: MA, TN

All Recalls

Class II: Risk 11/24/2025 device

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

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 device

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

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

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 device

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.
Class II: Risk 10/02/2024 device

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.
Class II: Risk 10/02/2024 device

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 08/12/2024 device

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Class II: Risk 08/12/2024 device

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
Class II: Risk 07/09/2024 device

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.
Class II: Risk 07/09/2024 device

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.
Class II: Risk 04/24/2024 device

Packaging contained the incorrect size of femoral head from what was displayed on the label.

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.