Recall Z-2370-2012 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Omni Life Science
Omnilife Science Apex Knee System Modular Tibia Augment, Size 1 x 4mm Ref: KC-54010. The Apex Knee System is intended for use as a primary or revision total knee replacement.
| Date | Sep 13, 2012 (initiated Aug 9, 2012) |
| Status | Terminated |
| Reason | The Apex Knee System Modular Tibia Augment may breach the inner and outer sterile pouches, compromising the sterility |
| Root cause | Packaging |
| Action | Omnilife Science contacted affected customers by phone and sent an "URGENT MEDICAL DEVICE RECALL" e-mail on August 9, 2012. The e-mail identifies the product, problem, and actions to be taken by the customers. Customers with questions regarding product return should contact Customer Service at 800-448-6664. Customers with questions regarding the recall should contact the firm at 774-226-1845. |
| Quantity | 312 units |
| Distribution | Worldwide Distribution-USA (nationwide including the states of CO, NY, OK, PA, UT, VA, and WI, and the countries of Spain and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K094017 | TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 Omni Life Science, Inc., Mar 5, 2010 |