Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.
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-0982-2015
- Quantity
- 15
- Firm Location
- Broomfield, CO
- Official Source
- View on FDA website ↗
Reason for Recall
The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly.
Distribution
Distributed in PR and the states of NY, AZ, TN, TX, and CA.
Lot / Code Info
Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013
Root Cause
Component design/selection
Action Taken
Distributors and Direct Sales Reps notified via letter to return product.
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