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Terminated

TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah Catalog: 09-42-0217, 09-11-0217. Left Fossa Component - DelCristo Catalog 09-42-0216, Left Ramus Component - DelCristo Catalog: 09-11-0216.

FDA Recall Z-1626-2010 · Posted 2010-05-20

Recalling FirmEndotec, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-06-05
Date Terminated2013-10-22
Product Quantity5 Pieces

Reason for Recall

Endotec is recalling B-P Hip, B-P Shoulder, and B-P Knee Replacement System devices due to sterility issues involving validation, process variations and test results.

Firm Action

Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.

Root Cause

Other

Distribution Pattern

Worldwide distribution -- US in OH, TX, CA, FL, NJ, TN; and International Distribution: Korea, Australia, Switzerland, The Netherlands, Spain. Domestic: OH, TX, CA, FL, NJ, TN.

Official Source

View FDA Recall →

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

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