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Terminated

Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left

FDA Recall Z-0826-2010 · Posted 2010-02-24

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-12-11
Date Terminated2010-09-24
Product Quantity17

Reason for Recall

Partial lot of product was not manufactured to specification. Central locking screw was missing threads. There is a potential for dissociation because the screw is not able to be used as a secondary fixation method.

Firm Action

Firm notified consignees by letter on 12/11/2009. The letter informs physicians that patients with implanted devices should counseled about the issue and should report any changes to their treating physician.

Root Cause

Process control

Distribution Pattern

TX, FL, GA, CA, AZ, Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K932425FOUNDATION MODULAR TIBIAL BASEPLATEEncore Orthopedics, Inc. · 1994-07-22

Official Source

View FDA Recall →

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

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