Recall Z-2603-2011 ยท MBL Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
Ortho Development Corporation
Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020. Intended for use in total hip arthroscopy. Device fixation is achieved by an optimal, press-fit in the medullary canal, which maximizes contact between the stem and the bone.
| Date | Jun 20, 2011 (initiated May 10, 2011) |
| Status | Terminated |
| Reason | Tests on PVC packaging material resulted in alert levels for cytotoxicity. |
| Root cause | Package design/selection |
| Action | Ortho Development Corporation notified consignees by letter on May 11, 2011. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to return all remaining affected units to Ortho. Replacement product was to be shipped by May 31. |
| Quantity | 113 units |
| Distribution | Nationwide Distribution - USA including CA, FL, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053293 | ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS Ortho Development Corp., Feb 16, 2006 |