Biomet Spine, LLC recalls Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lat…

Recall date

August 22, 2013

Source

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

Recall number

Z-0978-2015

FDA classification

Class II

Brand / firm

Biomet Spine, LLC

Sold / distributed

US Distribution to states of: AZ, CA, NY, TN, and TX including PR.

Why it was recalled

The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.

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

What was recalled

Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Lateral Variable Retractable Sleeves (the Sleeves) are used with the Timberline MPF System to help establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.