Recall Z-0825-2015 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
DePuy Orthopaedics, Inc.
Ceramic Femoral Head. Intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery.
| Date | Dec 17, 2014 (initiated Nov 7, 2014) |
| Status | Terminated |
| Reason | Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the taper connection between the femoral head and stem. The investigations found that the small size sleeve (+1.5 femoral head offset) was incorrectly used in the |
| Root cause | Mixed-up of materials/components |
| Action | On 11/7/2014, URGENT INFORMATION - RECALL NOTICE notifications were sent to the affected distributors, hospitals, and doctors with instructions for returning the affected product. All distributors were notified via electronic mail, and all hospitals and doctors were notified via sales consultant visit. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc. Scientific Information Of |
| Quantity | 19 units worldwide |
| Distribution | Distributed in the states of WV, AZ, and AL, and the countries of Germany, and Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071830 | DEPUY DELTA TS CERAMIC FEMORAL HEADS DePuy Orthopaedics, Inc., Sep 28, 2007 |