Device 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 Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones.
Z-2456-2015
Product summary
- Event
- Event 71815
- Status
- Terminated
- Classification
- Class II
- Quantity
- 638 units
- Official record key
device-enforcement:Z-2456-2015
Official wording
Reason: The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.
Code information: TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708
Distribution pattern: Nationwide throughout the US
Derived failure modes
-
Unknown
The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.