Hoffman LRF Telescopic Strut Short Stryker Stryker Trauma AG CH-2545 Seizach Distributed in the USA by Howmedica Osteoni
FDA device recall Z-0266-2013 · posted 2012-11-08 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Three complaints have been filed where the Hoffman LRF Telescopic Struts have broken during load bearing application by patients having a body weight greater than 250 LBS.
- Action taken
- Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE FIELD REMOVAL" letter dated July 2, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Business Reply Form was included for customers to complete and return to via fax to 1-865-252-3635. Contact the firm at 1-866-626-7747 for assistance.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KTT
- Quantity affected
- 165 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-07-03
- Date posted
- 2012-11-08
- Date terminated
- 2014-04-17
- Location
- Mahwah, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HOFFMANN LRF (LIMB RECONSTRUCTION FRAME) SYSTEM (K113327) | Stryker Corp. | 2012-03-29 |