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Terminated

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.

FDA Recall Z-2456-2015 · Posted 2015-08-24

Recalling FirmTrilliant Surgical Ltd.
Recall StatusTerminated
Product CodeHTO
Date Initiated2015-07-20
Date Terminated2017-01-26
Product Quantity638 units

Reason for Recall

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

Firm Action

The recalling firm sent out written notification of the recall on 7/3/14. The letter instructed the consignees to exchange affected instruments.

Root Cause

Component design/selection

Distribution Pattern

Nationwide throughout the US

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K121452GRIDLOCK PLATING SYSTEMTrilliant Surgical, Ltd. · 2012-08-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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