FDA-Device2015-01-21Class II
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable 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. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.
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.
Sold states
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
Affected count
14 units
Manufactured in
310 Interlocken Pkwy Ste 120, Broomfield, CO, United States
Products
Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable 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. The Timberline Retractable Drill and the Timberline Retractable Awl fit within this Sleeve. Spinal Surgical Device.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0983-2015Don't want to check this manually?
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