Offset Adaptor Trial - 2MM, Triathlon Revision Instruments. Non-Sterile; Howmedica Osteonics Corp: 325 Corporate Drive,
FDA device recall Z-1607-2009 · posted 2009-07-23 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Triathlon Offset Adaptors may seize during surgery and the OR staff may be unable to disassemble the instrument using the removal tool.
- Action taken
- "Urgent Product Correction" letters dated April 16, 2009 were sent to all Stryker Representatives, Hospital Rick Management Departments, Hospital Chief of Orthopaedics, Surgeon and countries by Federal Express. The notice explains the Issue, Potential Hazards and Risk Mitigation Factors of the affected product(s) including a request to complete and return the Product Correction Form. For further questions, contact Stryker Orthopedics, Division of Regulatory Reporting at 201-831-5970.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 2498 units total, all sizes.
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-04-16
- Date posted
- 2009-07-23
- Date terminated
- 2010-04-05
- 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 |
|---|---|---|
| TRIATHLON TS KNEE SYSTEM (K070095) | Howmedica Osteonics Corp. | 2007-06-01 |