FDA-Device2015-01-21Class II
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.
Biomet Spine, LLC
Hazard
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.
Sold states
US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
Affected count
12 units
Manufactured in
310 Interlocken Pkwy Ste 120, Broomfield, CO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0978-2015Don't want to check this manually?
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