FDA-Device2015-02-18Class II

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.

Biomet Spine, LLC
Hazard

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

Sold states
Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.
Affected count
213
Manufactured in
310 Interlocken Pkwy Ste 120, N/A, Broomfield, CO, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2015

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