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Smith & Nephew, Inc. recall records

27 reported ongoing

33 records in this archive. Latest source date Mar 16, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200 (SIZE 3-4), c) REF 1-10011-300 (SIZE 5-6)...

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 wi...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source
FDA device enforcement

Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-1...

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 wi...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source
FDA device enforcement

Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) R...

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 wi...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source
FDA device enforcement

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #71420166.

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.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO, MS, NC, NJ, NY, OR, SC, TN, VA, WA, and WI.

Official source
FDA device enforcement

Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 722...

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

Class IIReported ongoing

Distribution: Worldwide distribution - US Nationwide distribution in the states of CO, CT, FL, MA, MD, OR, PA, WI and the country of Canada.

Official source
FDA device enforcement

smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101

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.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

Official source
FDA device enforcement

smith&nephew EVOS MEDIAL DISTAL FEMUR PLATE, R, 5H, 90MM, REF 72573201

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.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

Official source
FDA device enforcement

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, L, 5H, 115MM, REF 72573102

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.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

Official source
FDA device enforcement

smith&nephew EVOS CONDYLAR MEDIAL DISTAL FEMUR PLATE, R, 5H, 115MM, REF 72573202

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.

Class IIReported terminated

Distribution: US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ, NV, NY, OH, OK, PA, TN, TX, WA.

Official source
FDA device enforcement

Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.

The labels on the packages of screws were switched.

Class IIReported ongoing

Distribution: Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. The...

Official source

Reasons in these listed records

  • 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 ri...
  • 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.
  • 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.
  • It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

These examples come from this result page and are not a ranking of every recall reason.

Checking Smith & Nephew, Inc.

Is there a recall on smith & nephew, inc. right now?

This archive contains 33 records, including 27 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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