2 — Class II medical device recall Z-0641-2017
Terminated recall by Synthes (USA) Products LLC, reported 2016-11-30, distributed nationwide. The peel pouches for the affected reaming rods and extraction hooks are delaminating.
| Recall number | Z-0641-2017 |
|---|---|
| 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 | 2016-10-03 |
| Classified | 2016-11-19 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-07-06 |
| Distributed | Nationwide (US) |
| Quantity | 139 units |
| Lot numbers | H085634, H094463 |
| Model numbers | 355.042S |
Product
2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
Reason for recall
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
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-0641-2017. 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.