Concave Reamer Head recall
Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex…
Why was Concave Reamer Head recalled?
The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
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?
TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708
- Product
- Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex…
- Recalling firm
- Trilliant Surgical Ltd.
- Quantity
- 638 units
- Distribution
- Nationwide throughout the US
- Recall date
- September 2, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)