Recall Z-0164-2012 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Biopro, Inc.
BioPro Femoral Head 28 mm +18, Item 19010. Orthopedic femoral head for implantation
| Date | Nov 4, 2011 (initiated Sep 21, 2011) |
| Status | Terminated |
| Reason | BioPro Femoral Head Outer Packaging was found lacking proper seal ,compromising sterility. |
| Root cause | Packaging |
| Action | Biopro, Inc notified all affected customers via telephone on September 21, 2011 with instructions to quarantine and return affected product to the manufacturer. The firm sent a follow up "RECALL NOTICE" dated September 29, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter gives instructions on how to return affected product. Contact Customer Service at 1-800-252-7707 for questions regarding this recall. |
| Quantity | 8 units |
| Distribution | USA (nationwide) including the states of FL, MI, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090208 | BIOPRO FEMORAL HEADS Biopro, Inc., May 22, 2009 |