Hoffman LRF Wire Bolt, Catalog number 4933-1-001 through -003.
FDA device recall Z-0695-2013 · posted 2013-01-17 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Two complaints have been filed where Hoffman LRF Wires have broken during load bearing application by patients.
- Action taken
- Stryker sent "Urgent Medical Device Removal" notification letters and acknowledgement forms dated 10/25/2012 via Fed Ex to Branches/Agencies with return receipt. Stryker sent notification letters/acknowledgement forms dated 10/26/202 via Fed Ex to Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letters described the device issue and provided recommended actions. Questions were directed to Stryker Customer Service.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 476 units
- Distribution
- Nationwide Distribution, including the states of PA, OH, NY, CA and IL.
- Date initiated
- 2012-10-25
- Date posted
- 2013-01-17
- Date terminated
- 2015-12-01
- 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 |
|---|---|---|
| HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K113327) | Stryker Corp. | 2012-03-29 |