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.
This recall has been terminated (originally issued January 14, 2015).
- Company
- Biomet Spine Llc.
- Recall Initiated
- August 22, 2013
- Posted
- January 14, 2015
- Terminated
- March 13, 2015
- Recall Number
- Z-0978-2015
- Quantity
- 12 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 shaft.
Distribution
US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
Lot / Code Info
Model 8630-0204 Lots TU00052, TU00052A, and TU00117
Root Cause
Component design/selection
Action Taken
The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com.