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.
This recall has been terminated (originally issued January 15, 2015).
- Company
- Biomet Spine Llc.
- Recall Initiated
- August 22, 2013
- Posted
- January 15, 2015
- Terminated
- March 13, 2015
- Recall Number
- Z-0983-2015
- Quantity
- 14 units
- Firm Location
- Broomfield, CO
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
US Distribution to states of: AZ, CA, NY, TN and TX including PR.
Lot / Code Info
LOT Numbers: TU00053A, TU00053B and TU00118 Product Code: 86300205
Root Cause
Device Design
Action Taken
The firm, Lanx, sent a letter to their Consignees/customers dated October 15, 2013. The letter describes the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with conforming product. Please contact Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com if you have any questions regarding this recall.