TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah Catalog: 09-42-0217, 09-11-0217. Left
FDA device recall Z-1626-2010 · posted 2010-05-20 · Terminated
Recall details
- Recalling firm
- Endotec, Inc.
- 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.
- Action taken
- Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 5 Pieces
- Distribution
- 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.
- Date initiated
- 2009-06-05
- Date posted
- 2010-05-20
- Date terminated
- 2013-10-22
- Location
- Orlando, FL
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