DePuy Synthes 6 — Class II medical device recall Z-1915-2015
Terminated recall by Synthes, Inc., reported 2015-07-08, distributed nationwide. certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthe
| Recall number | Z-1915-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Synthes, Inc., West Chester, PA, United States |
| Recall initiated | 2015-05-27 |
| Classified | 2015-06-26 |
| Reported by FDA | 2015-07-08 |
| Terminated | 2015-12-18 |
| Distributed | Nationwide (US) |
| Quantity | 276 |
| Lot numbers | 8534954, 8556018, 8556020, 8638955, 8638957, 8638958, 8653032, 8653036 |
| Model numbers | 04.003.024, 04.003.025, 04.003.026, 04.003.027, 04.003.028, 04.003.029, 04.003.031 |
Product
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
Reason for recall
certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components).
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-1915-2015. 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.