DePuy Synthes 8 — Class II medical device recall Z-1912-2016
Terminated recall by Synthes (USA) Products LLC, reported 2016-06-15, distributed nationwide. Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions.
| Recall number | Z-1912-2016 |
|---|---|
| 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 | 2016-05-02 |
| Classified | 2016-06-06 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 244 units |
| Lot numbers | 3007721, 3148892, 3175201, 3175202, 3175916, 3921562, 3928332, 3935789, 3945479, 3996999, 3997000, 3997338, 4307973, 4326050, 4387338, 4441055, 4441056, 4441079, 4559672, 4561383, 4619549, 4738380, 4816738, 4816739, 5407442, 5582819, 5722664, 5786778, 5800844, 5813837, 5903413, 5910995, A3CN449, XXX5071, XXX5072, XXX5073 |
| Model numbers | 351.43 |
Product
DePuy Synthes 8.0 mm Flexible Shaft Reamer, 360 mm, Orthopedic manual surgical instrument. Part number 351.43
Reason for recall
Devices did not pass the biological safety evaluation for cytotoxicity following exposure to test conditions. The high growth inhibition levels observed during testing could be attributed to corrosion of the device at solder points. This could potentially be reproduced during use and reprocessing.
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-1912-2016. 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.