FDA Device recall Z-0644-2017
2.5 mm Reaming Rod W/Ball Tip 650 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 W/Ball Tip 650 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-0644-2017 |
| 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 W/Ball Tip 650 mm, Sterile
Reason
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Identifiers
| code_info | Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950…Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530. |
|---|
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-0644-2017%22
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