2.5 mm Reaming Rod W/Ball Tip 650 mm recall
2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
Why was 2.5 mm Reaming Rod W/Ball Tip 650 mm recalled?
The peel pouches for the affected reaming rods and extraction hooks are delaminating.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 2,157 units
- Distribution
- Distributed Nationwide
- Recall date
- November 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)