Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics,
FDA device recall Z-0761-2010 · posted 2010-02-01 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
- Action taken
- An "Urgent Product Recall" Letter dated December 10, 2009 was sent by Federal Express to all Stryker Branches, Chief of Orthopaedics, Hospital Risk Management and Surgeons. The letter described the affected product, issue and potential hazards. Consignees were instructed to complete Product Recall Acknowledgement Form and return to Stryker Orthopaedics via fax at 1-201-831-6069. All questions regarding the recall should be directed to Stryker Orthopaedics at 1-201-972-2100.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 9
- Distribution
- Worldwide Distribution -- United States (DE, NC, OH. MI, TX, CA, MA, NJ, TN, KS, GA, FL, AL, IN, MN, MD, NE, AR, OK, CO, AZ, OR, and MA), Australia, United Kingdom and Canada.
- Date initiated
- 2009-12-10
- Date posted
- 2010-02-01
- Date terminated
- 2012-08-28
- 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 |