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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

232

Past Year

5

Class I (Serious)

1

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 101–120 of 232 recalls

EVOS Screws (Smith & Nephew) – Expiration Date Error (2020)

Multiple or incorrect expiration dates were provided on the affected designation labels.

FDAAug 24, 2020Nationwide• Smith & Nephew, Inc.

RIKKI Retractor (Smith & Nephew) – improper heat treatment (2020)

The products were improperly heat treated.

FDAAug 3, 2020CA, CO, CT +15 more• Smith & Nephew, Inc.

Tibial Knee Prosthesis (Smith & Nephew) - Material Defect (2020)

Due to an inconsistency in the raw material process, specific lots may contain units with internal non-homogenous material defects.

FDAJul 16, 2020AL, AZ, AR +22 more• Smith & Nephew, Inc.

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PeriLoc Targeter (Smith & Nephew) – Incorrect Hand Marking (2020)

The 4.5MM PeriLoc Targeter right hand part was anodized green and was marked as a left-hand part.

FDAJun 29, 2020Nationwide• Smith & Nephew, Inc.

SutureFixx Ultra (Smith & Nephew) – Drill Size Packaging Error (2020)

A packaging error resulted in a XL drill being presented for use instead of the S drill. The XL drill is one inch longer than the S drill.

FDAJun 24, 2020AL, AZ, AR +20 more• Smith & Nephew, Inc.

TRIGEN Intramedullary Nail (Smith & Nephew) – Sterilization Issue (2020)

A manufacturing error which resulted in the re-sterilization of the ultra-high-molecular-weight polyethylene (UHMWPE) sleeve.

FDAJun 24, 2020IN• Smith & Nephew, Inc.

Smith & Nephew T-Fix Drill Pac (Smith & Nephew) – Sleeve Shortage (2020)

The T-Fix sterile package contains only one sleeve instead of two, The device will not perform as intended for the second bone tunnel due to the absence of thesleeve

FDAJun 24, 2020Nationwide• Smith & Nephew, Inc.

smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHE... (Smith & Nephew, Inc.) – a manufacturing error resulted in out... (2020)

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.

smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED ... (Smith & Nephew, Inc.) – a manufacturing error resulted in out... (2020)

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.

smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTIT... (Smith & Nephew, Inc.) – a manufacturing error resulted in out... (2020)

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.

smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED ... (Smith & Nephew, Inc.) – a manufacturing error resulted in out... (2020)

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.

smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTI... (Smith & Nephew, Inc.) – a manufacturing error resulted in out... (2020)

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.

R3 Multi-Hole HA Coated Hemispherical Stiktite Shell (Smith & Nephew) – Manufacturing Error (2020)

A manufacturing error resulted in out of specification R3 Acetabular Shells

FDAApr 22, 2020Nationwide• Smith & Nephew, Inc.

Bard Peripheral Vascular Inc: Jamshidi Bone Marrow Biopsy/Aspiration Needle, with Luer ...

Sterility compromised due to packaging pouches that may not be sealed properly

FDAMar 17, 2020Nationwide• Bard Peripheral Vascular Inc

Smith & Nephew, Inc.: Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part...

Space between the device and the packaging permits excessive movement which could potentially lead to the displacement of the anchors tip protector allowing the tip of the anchor to create a sterile breach.

FDAMar 17, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: NAVIO Soft Tissue Protector, included in instrument kits....

Potential for the NAVIO Soft Tissue Protector to become stuck or bound to the bone pin intraoperatively when inserting the NAVIO bone pins.

FDAFeb 27, 2020Nationwide• Smith & Nephew, Inc.

Smith & Nephew, Inc.: JOURNEY II UNI RESECTION PREP TRIAL, LEFT MEDIAL/ RIGHT L...

The spike rail was manufactured with an oversized thru-hole which could potentially cause the dowel pin to fall out and the device to disassemble.

FDAJan 28, 2020Nationwide• Smith & Nephew, Inc.

Bard Peripheral Vascular Inc: BARD Access Systems PowerPort ClearVUE Slim Implantable P...

The catheter locks for the lot may contain an 8Fr catheter lock instead of a 6Fr catheter lock per device labeling.

FDAJan 15, 2020Nationwide• Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc: Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF ...

Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

FDAJan 3, 2020AZ, CA, CO +27 more• Bard Peripheral Vascular Inc

Bard Peripheral Vascular Inc: Bard Biopsy EnCor Probe, MRI, 7G Trocar Tip, REF number E...

Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.

FDAJan 3, 2020AZ, CA, CO +27 more• Bard Peripheral Vascular Inc