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Terminated

Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.

FDA Recall Z-0331-06 · Posted 2005-12-29

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-11-03
Date Terminated2008-04-04
Product Quantity16 units.

Reason for Recall

The product is mislabeled in that Size 6 right Foundation may contain size 8 right 3D knee non-porous baseplates and vice versa. Device is intended to aid surgeon in relieving knee pain and restoring knee joint function.

Firm Action

Firm initiated recall on 11/03/05 via letter to all consignees.

Root Cause

Other

Distribution Pattern

Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.

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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