Recall Z-0644-2022 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Howmedica Osteonics Corp.
32MM -4 V40 TAPER VIT HEAD, Catalog Number 6260-5-032
| Date | Dec 21, 2021 |
| Status | Open, Classified |
| Reason | There is a potential for the outer Tyvek lid to de-bond from the sealed package. |
| Root cause | Under Investigation by firm |
| Action | An URGENT MEDICAL DEVICE RECALL UPDATE notification letter dated 12/21/21 was sent to customers. Recommendations for Patient Follow-Up Patients should continue to be followed per the normal protocol established by his/her surgeon. There are no recommended changes to the frequency of the standard follow-up care protocol. 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 important follow up communication. We therefore |
| Quantity | 8 units |
| Distribution | Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121308 | HIP SYSTEMS Howmedica Osteonics Corp., Jul 30, 2012 |