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Terminated

Foundation Knee System, non-porous Femur Size 8, Right

FDA Recall Z-1069-03 · Posted 2003-07-30

Recalling FirmEncore Medical, LP
Recall StatusTerminated
Product CodeJWH
Date Initiated2003-04-24
Date Terminated2003-07-29
Product Quantity14 unimplanted units

Reason for Recall

Product container was labeled incorrectly indicating left femur instead of right.

Firm Action

The firm recalled non-implanted devices. The firm initiated the recall on 04/23/2003 via phone to sales representatives and foreign distributors.

Root Cause

Other

Distribution Pattern

PA, TX, MA, FL, NV, AZ, and France and Saudi Arabia

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K923277FOUNDATION KNEE SYSTEMEncore Orthopedics, Inc. · 1993-02-09

Official Source

View FDA Recall →

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

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