Recall Z-0261-2016 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
| Date | Nov 10, 2015 (initiated Sep 8, 2015) |
| Status | Terminated |
| Reason | Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery. |
| Root cause | Process design |
| Action | Stryker sent an Urgent Medical Device Recall Notifiications dated September 9 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are asked to complete the attached form and return within 5 days by using email strykerortho6632@stericycle.com or FAX 1-888-965-5803. For further questions please call ( 201) 831-5000. |
| Quantity | 201 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121308 | HIP SYSTEMS Howmedica Osteonics Corp., Jul 30, 2012 |