Stryker Orthopaedics Tapers LFIT V40 Vitallium femoral heads. hip prosthesis component.
FDA device recall Z-0261-2016 · posted 2015-11-10 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Complaints that the femoral head could not be assembled with its corresponding V40 stem trunnion at the time of surgery.
- Action taken
- 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.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 201
- Distribution
- Nationwide Distribution
- Date initiated
- 2015-09-08
- Date posted
- 2015-11-10
- Date terminated
- 2017-07-25
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HIP SYSTEMS (K121308) | Howmedica Osteonics Corp. | 2012-07-30 |