Recall Z-0982-2015
Biomet Spine, LLC · initiated August 22, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013
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.
FDA-determined cause: Component design/selection
Action taken
Distributors and Direct Sales Reps notified via letter to return product.
Details
- Recall number
- Z-0982-2015
- Initiated
- August 22, 2013
- Posted by FDA
- January 15, 2015
- Terminated
- March 13, 2015
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Quantity
- 15
- Distribution
- Distributed in PR and the states of NY, AZ, TN, TX, and CA.
- Recalling firm
- Biomet Spine, LLC, Broomfield, CO