FDA Device recall Z-0643-2017
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile by Synthes Usa Products, citing the peel pouches for the affected reaming rods and extraction hooks are delaminating.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0643-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-03 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Synthes Usa Products |
| Distribution | US |
Product
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Reason
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Identifiers
| code_info | Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0643-2017%22
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