Biomet Spine, LLC: Medical Device Recall in 2015 - (Recall #: Z-0982-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2015.
Data Source: FDA.
Product Description:
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.
Product Classification:
Class II
Date Initiated: August 22, 2013
Date Posted: January 21, 2015
Recall Number: Z-0982-2015
Event ID: 70056
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.
Status: Terminated
Product Quantity: 15
Code Information:
Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013
Distribution Pattern:
Distributed in PR and the states of NY, AZ, TN, TX, and CA.
Voluntary or Mandated:
Voluntary: Firm initiated