Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Steril
FDA device recall Z-1621-2010 · 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
- 3169 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 (B-P) FIXED BEARING NEW JERSEY (NJ) TOTAL KNEE, MODEL 1 (K012702) | Endotec, Inc. | 2002-01-30 |