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Terminated

Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.

FDA Recall Z-0057-2007 · Posted 2006-10-21

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2006-09-14
Date Terminated2007-04-26
Product Quantity9

Reason for Recall

Mislabeled: units containing a size 32 mm. patella were labeled as a 38 mm patella.

Firm Action

The firm called their sales staff on 9/14/06 and instructed them to place a hold on the product, which entails pulling products from their own inventory and at any hospitals where it has been placed on consignment. Sales staff immediately visited hospital accounts and switched out the recalled lot for other product.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K961685P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)Johnson & Johnson Professionals, Inc. · 1996-07-10

Official Source

View FDA Recall →

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

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