ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Tec
FDA device recall Z-1215-2010 · posted 2010-03-31 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- The product contained screws with the incorrect length (incorrectly contained 15 mm length screws instead of the correct 5 mm length screws).
- Action taken
- The firm initiated their recall of the product by letter on February 19, 2010. The notification letters were addressed to distributors, hospital administrators, and surgeons with a fax back response form. The letter described the affected product and reason for the recall. Customers were instructed to examine their inventory and return the recalled product to Wright Medical Technology, Inc. Customers may contact Customer Service by calling 1-800-238-7117 for return instructions and replacement inventory. Direct questions regarding this matter to Wright Medical Technology, Inc. by calling 1-800-874-5630.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 47 units
- Distribution
- Worldwide Distribution -- United States, Canada, Netherlands, Germany, Japan, S. Korea, UK, Czech Republic, Turkey and Brazil.
- Date initiated
- 2010-02-19
- Date posted
- 2010-03-31
- Date terminated
- 2011-07-08
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANCE MODULAR TIBIAL COMPONENT (K973524) | Wrightmedicaltechnologyinc | 1997-12-12 |