Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component
FDA device recall Z-1627-2010 · 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
- 156 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
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX (K960425) | Endotec, Inc. | 1996-10-03 |
| MODIFIED NEW JERSEY FEMORAL HIP RESURFACING COMPON (K904870) | Endotec, Inc. | 1991-05-23 |
| NEW JERSEY FEMORAL STEM (K842234) | Endomedics, Inc. | 1984-07-20 |