FDA Device recall Z-0637-2017
2.5 mm Reaming Rod with Ball Tip & Extension/950 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 Reaming Rod with Ball Tip & Extension/950 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-0637-2017 |
| 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 Reaming Rod with Ball Tip & Extension/950 mm, Sterile
Reason
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Identifiers
| code_info | Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040…Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875. |
|---|
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-0637-2017%22
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