Home / Recalls / Biomet Spine, LLC / Z-0982-2015

Z-0982-2015 Class II Terminated

Recalled by Biomet Spine, LLC — Broomfield, CO

Recall Details

Product Type
Devices
Report Date
January 21, 2015
Initiation Date
August 22, 2013
Termination Date
March 13, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
15

Product Description

Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

Reason for Recall

The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.

Distribution Pattern

Distributed in PR and the states of NY, AZ, TN, TX, and CA.

Code Information

Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013

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