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Terminated

Genesis Uni Articular Inserts

FDA Recall Z-0304-05 · Posted 2004-12-14

Recalling FirmSmith & Nephew Inc
Recall StatusTerminated
Product CodeHSX
Date Initiated2004-06-21
Date Terminated2006-02-15
Product Quantity11,339 units were distributed

Reason for Recall

The firm received confirmed reports of Genesis Uni Articular Inserts not locking into tibial base plates intraoperatively.

Firm Action

Recall notification was initiated by letter (Fed Ex) to domestic territory manager and sales representative and to international distributors (via email) on 06/21/2004 to request the return of any in stock product.

Root Cause

Other

Distribution Pattern

Nationwide, 43 consignees, 17 countries: Germany, France, Australia, Italy, Switzerland, United Arab Emirates, Belgium, Japan, United Kingdom, Singapore, Spain, Taiwan. Sweden, Canada Venezuela, South Africa, and Israel.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K912735GENESIS UNICOMPARTMENTAL KNEE SYSTEMSmith & Nephew Richards, Inc. · 1991-12-27

Official Source

View FDA Recall →

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

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