Biomet Spine, LLC recalls Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retra…

Recall date

August 22, 2013

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0982-2015

FDA classification

Class II

Brand / firm

Biomet Spine, LLC

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.