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Recall Observatory FDA recall evidence

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

July 20, 2015

Class II

Product summary

Firm
Trilliant Surgical Ltd.
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

    reason.no_named_rule · v1.0.0

    The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through.