FDA Device recall Z-2091-2015
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA)
- FDA Device
- Class II
- terminated
- Published 2015-07-22
On 2015-07-22 the FDA classified a Class II recall of Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA) by Synthes Usa Products, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-06-10 |
| Published | 2015-07-22 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED (TFNA); intended to secure the head element to the head element inserter to prevent disengagement during head element insertion. Manual orthopedic surgical instrument.
Reason
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).
Identifiers
| code_info | Part Number Lot Numbers 03.037.024 T102759 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2015%22
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