Biomet Spine, LLC recalls Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided w…

Recall date

February 22, 2012

Source

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

Recall number

Z-1069-2015

FDA classification

Class II

Brand / firm

Biomet Spine, LLC

Sold / distributed

Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.

Why it was recalled

Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.

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 Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.