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Terminated

GENESIS II NON-POROUS CRUCIATE RETAINING FEMORAL COMPONENT, SIZE 6 RIGHT, REF 71420026 Knee prosthesis

FDA Recall Z-2883-2018 · Posted None

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-08-01
Date Terminated2019-02-19
Product Quantity27 units

Reason for Recall

Two lots of Genesis II Non Porous C/R Femoral Size 6 right packaged were distributed containing Genesis II C/R Femoral Size 4 left.

Firm Action

The firm notified its consignees of the problem and the recall by email on 08/01/2018. The firm requested the return of the product.

Root Cause

Employee error

Distribution Pattern

Australia, Austria, Germany, Great Britain, Poland, Spain

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K951987GENESIS II TOTAL KNEE SYSTEMSmith & Nephew Richards, Inc. · 1995-08-22

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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