Recall Z-1626-2010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Endotec, Inc.
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.
| Date | May 20, 2010 (initiated Jun 5, 2009) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Recall Letters were sent to each distributor on 06/07/2009. Questions are directed to Endotec at (407) 822-0021. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.