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Terminated

Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size 3 Talar Component Catalog: 05-01-0003, Size 4 Talar Component Catalog: 05-01-0004, Size 5 Talar Component Catalog: 05-01-0005, BP Ankle System, Thick Talar Ankle Component: Size 2 Thick Talar Component Catalog: 05-11-0002, Size 3 Thick Talar Component Catalog: 05-11-0003, Size 5 Thick Talar Component Catalog: 05-11-0005, B-P Ankle System, Tibial Component: Size 2 Tibial Component 05-03-0002, Size 3 Tibial Component 05-03-0003, Size 4 Tibial Component 05-03-0004, Size 5 Tibial Component 05-03-0005,

FDA Recall Z-1624-2010 · Posted 2010-05-20

Recalling FirmEndotec, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-06-05
Date Terminated2013-10-22
Product Quantity43 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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K960425BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXXEndotec, Inc. · 1996-10-03K904870MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPONEndotec, Inc. · 1991-05-23K842234NEW JERSEY FEMORAL STEMEndomedics, Inc. · 1984-07-20

Official Source

View FDA Recall →

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

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