Home / Recalls / Medical Devices
Biomet Spine, LLC recalls Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable
Recalled January 21, 2015 · FDA recall Z-0983-2015 · Biomet Spine
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. · FDA Class II
Units
14 units
Sold at
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
Description
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.
Product
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.
Manufacturer(s)
Biomet Spine, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →