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Terminated

P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703

FDA Recall Z-1369-04 · Posted 2004-08-24

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2003-12-22
Date Terminated2004-09-23
Product Quantity1 unit

Reason for Recall

The collar was incorrectly etched for the R (right) and L (Left) orientation

Firm Action

Depuy notified distributors at the various territories via verbal contact on 12/23/2003

Root Cause

Other

Distribution Pattern

NY

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K952830DARWIN KNEE SYSTEM (TC3)Johnson & Johnson Professionals, Inc. · 1996-01-18

Official Source

View FDA Recall →

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

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