FDA Device recall Z-0640-2017
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of 3.0 mm Guide Rod/950 mm with Smooth Tip, 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-0640-2017 |
| 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
3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
Reason
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Identifiers
| code_info | Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756 |
|---|
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-0640-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.