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Recall

Class II — Smith & Nephew, Inc.

Recalling firmSmith & Nephew, Inc.
Registered facilityView this company's 15 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonTwo lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.
ProductGENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis
Quantity27 units
DistributionAustralia, Austria, Germany, Great Britain, Poland, Spain
Initiated2017-08-01
Classified2018-08-22
Terminated2019-02-19
Recall numberZ-2883-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Smith & Nephew, Inc. (Z-2883-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/80752/

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