2 — Class II medical device recall Z-0906-2018
Terminated recall by Synthes (USA) Products LLC, reported 2018-03-14, distributed nationwide. Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
| Recall number | Z-0906-2018 |
|---|---|
| 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 | 2017-07-26 |
| Classified | 2018-03-05 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-09-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 63 |
| Reason classes | sterility, packaging |
| Model numbers | 359.083S |
Product
2.5 mm Titanium Calibrated Reaming Rod, 850 mm, Part Number: 359.083S Reaming Rods are intended for guiding of reamers during orthopedic surgery.
Reason for recall
Possible lack of product sterility due to potential gaps/channeling in the seal of the package.
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-0906-2018. 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.