FDA-Device2015-01-21Class II
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.
Biomet Spine, LLC
Hazard
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.
Sold states
Distributed in PR and the states of NY, AZ, TN, TX, and CA.
Affected count
15
Manufactured in
310 Interlocken Pkwy Ste 120, Broomfield, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0982-2015Don't want to check this manually?
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