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Terminated

P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178

FDA Recall Z-1382-04 · Posted 2004-08-24

Recalling FirmDepuy Orthopaedics, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2004-01-15
Date Terminated2004-09-23
Product Quantity1 unit

Reason for Recall

Screw size included in system was incorrect

Firm Action

DePuy notified the sales territories via verbal contact with the distributors on 1/15/04.

Root Cause

Other

Distribution Pattern

IA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923807P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUSJohnson & Johnson International · 1992-11-09

Official Source

View FDA Recall →

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

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