Helical Blade Inserter for Trochanteric Fixation Nail-ADVANCED — Class II medical device recall Z-2091-2015
Terminated recall by Synthes (USA) Products LLC, reported 2015-07-22, distributed nationwide. The height of one of the three guiding pins of the Helical Blade Inserter for the TFNA is oversized. The Helic
| Recall number | Z-2091-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes (USA) Products LLC, West Chester, PA, United States |
| Recall initiated | 2015-06-10 |
| Classified | 2015-07-16 |
| Reported by FDA | 2015-07-22 |
| Terminated | 2016-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 32 |
| Lot numbers | 03.037.024, T102759 |
| Model numbers | 03.037.024, T102759 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2091-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.