TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device is indicated for degeneration, deformity, o
FDA device recall Z-2088-2008 · posted 2008-09-16 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- One of the distal locking screw holes on a hindfoot fusion nail was drilled with an incorrect trajectory.
- Action taken
- All affected Smith & Nephew Sales Representatives were notified of problem and the recall via certified letter and e-mail on 4-22-08. All affected Smith & Nephew International Distributors were notified via email on 4-22-08 and 4-23-08. They were instructed to immediately notify their accounts concerning the recall. If you have questions, contact Customer Service at 800-238-7538.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 16
- Distribution
- Nationwide and Australia, Belgium, Canada, Denmark, France, Germany, Italy, The Netherlands, Norway, South Africa, Spain, Sweden, and United Kingdom.
- Date initiated
- 2008-04-22
- Date posted
- 2008-09-16
- Date terminated
- 2010-05-28
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIGEN HINDFOOT FUSION NAIL (K043052) | Smith & Nephew, Inc. | 2004-11-24 |