CLAW HEX SCREW CHARLOTTE " F&A SYSTEM CONTENTS: 1 EACH Foot and Ankle Screw ... IMPLANT MATERIAL: Stainless Steel Ref: 4
FDA device recall Z-2188-2010 · posted 2010-08-09 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- Reason for recall
- One lot of CLAW Hex Foot and Ankle Screws was incorrectly packaged containing Multi-use Compression Screws.
- Action taken
- The firm initiated their recall to their sales representatives (distributors) via telephone on 06/07/2010 and followed with a letter dated June 15, 2010 sent via Fed Ex on 06/28/2010. The hospital involved was also notified by letter on 06/29/2010. The letter described the product, the problem,and the action to be taken by the customers. The customers were instructed to immediately return any affected product to Wright as soon as possible, and to complete an attached response form confirming receipt of the notice and return a copy by fax to 901-867-7401. Customers may contact customer service for return instructions and replacement inventory at 800-238-7117. If you have any questions regarding this matter, contact Debby Daurer at 800-874-5630.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 8 units
- Distribution
- Nationwide Distribution in States of FL, PA, KS, IN, MO, and CA
- Date initiated
- 2010-06-07
- Date posted
- 2010-08-09
- Date terminated
- 2011-11-23
- Location
- Arlington, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHARLOTTE CLAW 3.5 (K080295) | Wrightmedicaltechnologyinc | 2008-02-27 |