2.5 mm TI Calibrated Reaming Rod 850 mm recall
2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
Why was 2.5 mm TI Calibrated Reaming Rod 850 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 359.083S, Lot Numbers: H115566; H116597; H116601; H117049
- Product
- 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 260 units
- Distribution
- Distributed Nationwide
- Recall date
- November 30, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)