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Smith & Nephew, Inc.

Smith & Nephew, Inc. Recalls

All product recalls associated with Smith & Nephew, Inc..

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 66 recalls

BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fix... (Smith & Nephew, Inc.) – removal of affected lot of screws due... (2025)

Removal of affected lot of screws due to labeling error.

Moderate

FDANov 24, 2025Nationwide• Smith & Nephew, Inc.

META-TAN Screw Kit (Smith & Nephew) – compression screw issue (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.

Moderate

FDAMar 18, 2025Nationwide• Smith & Nephew, Inc.

BIORAPTOR Suture Anchors (Smith & Nephew) – packaging sterility breach (2024)

Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

Moderate

12 3 4

Page 1 of 4Next

FDA

Oct 29, 2024

Nationwide

• Smith & Nephew Inc.

Tandem Bipolar Shell (Smith & Nephew) – Retaining Ring Size (2024)

The Bipolar assembly contains an oversized Retainer Ring.

Moderate

FDAOct 15, 2024Nationwide• Smith & Nephew, Inc.

Legion Oxinium Constrained Femoral Component (Smith & Nephew) – Implant Mislabeling (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.

Moderate

FDAOct 2, 2024TX• Smith & Nephew Inc

Genesis II Posterior Stabilized Femoral Component (Smith & Nephew) – Implant Mislabeling (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.

Moderate

FDAOct 2, 2024AL, CA, DE +4 more• Smith & Nephew Inc

Legion Oxinium Posterior Stabilized Component (Smith & Nephew) – Implant Mislabeling (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.

Moderate

FDAOct 2, 2024AL, CA, DE +4 more• Smith & Nephew Inc

Rotation Medical Tendon Staples (Smith & Nephew) - Packaging Seal Defect (2024)

Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility

Moderate

FDAAug 12, 2024Nationwide• Smith & Nephew Inc.

Diamond Point K-Wire (Smith & Nephew) – Packaging Error (2024)

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.

Moderate

FDAJul 9, 2024Nationwide• Smith & Nephew, Inc.

Smith & Nephew Inc: smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 713432...

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

Moderate

FDAApr 24, 2024Nationwide• Smith & Nephew Inc

Smith & Nephew, Inc.: JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF...

The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM.

Moderate

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 ...

Moderate

FDASep 27, 2023Nationwide• Smith & Nephew, Inc.

Smith & Nephew Inc: smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS...

The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.

Moderate

FDAAug 31, 2023CA, CT, NE +4 more• Smith & Nephew Inc

Smith & Nephew, Inc.: TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130...

A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT as described on the product label.

Moderate

FDAJul 24, 2023CA, DE, PA• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Smith&Nephew ENGAGE Cementless Partial Knee System, Porou...

Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.

Moderate

FDAMay 2, 2023Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM

A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.

Moderate

FDAMar 27, 2023Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, ...

The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.

Moderate

FDAJun 27, 2022Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND

The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw

Moderate

FDAJan 4, 2022Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: Acufex Access Advanced Positioning Kit - indicated for us...

Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process

Moderate

FDADec 14, 2021Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM,...

Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large Fragment Plating System.

Moderate

FDANov 1, 2021Nationwide• Smith & Nephew, Inc.