Recall Z-0514-2020 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Howmedica Osteonics Corp.
Stryker X-Change Medial Wall Mesh Small (6-Petal)-Intended to be implanted to replace a hip joint REF 0942-8-025
| Date | Oct 3, 2019 |
| Status | Terminated |
| Reason | Boxes of the 6-Petal X-Change Wall Mesh Small (Part # 0942-8-025) contain the 4-Petal X-Change Wall Mesh Small (Part # 0942-8-015) |
| Root cause | Employee error |
| Action | Stryker issued An Urgent Field Safety Notice (FSN), PFA 2197654, was issued to all affected OUS consignees at country level on October 03, 2019. Action to take: Actions to be taken by the Customer/ User: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all 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 facility. A response is required, even though you may not have any physical inventory on site anymore. 3. Q |
| Quantity | 40 units |
| Distribution | Foreign: Australia, France, Finland, Germany, Italy, Japan, New Zealand, Netherlands, Norway, Romania, Spain, Sweden and UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121308 | HIP SYSTEMS Howmedica Osteonics Corp., Jul 30, 2012 |