VALOR(TM) TTC FUSION, INSTRUMENT KIT, REF 4150-KIT1, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN
FDA device recall Z-1485-2012 · posted 2012-05-02 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The possibility exists that the handle of the targeting guide may rotate and/or break under normal usage.
- Action taken
- Wright Medical Technology, Inc. sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated April 2, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to check their stock and to return the affected product to the firm. Additionally, a Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact the firm at 901-867-4324 for questions regarding this notice.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 133 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the country of Australia.
- Date initiated
- 2012-04-05
- Date posted
- 2012-05-02
- Date terminated
- 2013-01-28
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VALOR ANKLE FUSION NAIL SYSTEM (K090857) | Wrightmedicaltechnologyinc | 2009-07-14 |