Recall Z-0811-2020 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Howmedica Osteonics Corp.
Stryker Omnifit Crossfire 10 Degree Series II Insert- intended for cementless and/or cemented fixation within the prepared acetabulum Catalog #: 2041C-3254
| Date | Nov 7, 2019 |
| Status | Terminated |
| Reason | May have a missing locking wire causing delay in surgery while retrieving a back-up device or implantation of a device that is missing a locking wire |
| Root cause | Employee error |
| Action | Stryker issued Urgent Medical Device Recall - PFA 2147264 letter dated November 7, 2019) to US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. Letter states reason for recall, health risk and action to take: Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your faci |
| Quantity | 20 units |
| Distribution | CA, FL, GA , IA, MA, MI, NC, OH, WI Foreign: Canada, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS Osteonics Corp., Sep 22, 1998 |