Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head e
FDA device recall Z-2091-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helical Blade Inserter is therefore unable to pass through the Blade/Screw Guide Sleeve (part 03.037.017).
- Action taken
- A recall notification letter, dated June 10, 2015, was sent to sales consultants and Synthes distribution sites requesting return of affected devices.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSB
- Quantity affected
- 32
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-06-10
- Date posted
- 2015-07-16
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES TROCHANTERIC FIXATION NAIL - ADVANCED SYSTEM (K131548) | Synthes (USA) Products, LLC | 2014-02-28 |