2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
This recall has been terminated (originally issued November 19, 2016).
- Company
- Synthes (Usa) Products Llc
- Recall Initiated
- October 3, 2016
- Posted
- November 19, 2016
- Terminated
- July 6, 2017
- Recall Number
- Z-0644-2017
- Quantity
- 2,157 units
- Firm Location
- West Chester, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
Distribution
Distributed Nationwide
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.