LFT v40 Femoral Head; Catalog Number 6260-9-032; V40 CoCr LFit Head 32mm/-4. Designed to be assembled onto a femoral hip
FDA device recall Z-1241-2015 · posted 2015-03-03 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Three customer complaints were received for the same batch of V40 LFIT Vitallium femoral heads (part number 6260-9-032, lot 48681201) alleging that the femoral head couldn't be assembled with its corresponding V40 stem trunnion.
- Action taken
- Branches/Agencies were notified of this action by e-mail on December 19, 2014 and were asked to quarantine affected devices. Notification Letters and Product Accountability Forms were sent to Hospital Risk Management and Chief of Orthopaedics via FedEx (with return receipt) by 2/3/2015.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 9 units
- Distribution
- Distributed in the states of GA, MA, NC, NY & PA.
- Date initiated
- 2015-02-03
- Date posted
- 2015-03-03
- Date terminated
- 2017-04-07
- 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 |
|---|---|---|
| LFIT V40 FEMORAL HEAD COMPONENTS (K010757) | Howmedica Osteonics Corp. | 2001-04-11 |