Recall Z-0651-2022 ยท JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Howmedica Osteonics Corp.
Exeter V40 Cemented Hip (125mm) Stem, Part Number 0580-1-044
| Date | Dec 30, 2021 |
| Status | Terminated |
| Reason | There is a potential label mix between certain lots of Exeter V40 Cemented Hip (125mm) Stem and Exeter V40 Cemented Hip (150mm) Stem. |
| Root cause | Labeling mix-ups |
| Action | An URGENT MEDICAL DEVICE RECALL dated 12/30/21 was sent to customers. Actions Needed: Our records indicate that you may have received the affected product(s). It is Stryker s responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals who need to be made aware. 2. Immediately check all stock areas and/or operating room sto |
| Quantity | 59 devices |
| Distribution | The product was distributed to the following US states: MI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121308 | HIP SYSTEMS Howmedica Osteonics Corp., Jul 30, 2012 |