Recall Z-0982-2015— Biomet Spine, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet Spine, LLC, initiated 2013-08-22, terminated 2015-03-13. It names one FDA 510(k) clearance: K123767. 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.. Reason: 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..
- Recalling firm
- Biomet Spine, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-22
- Terminated
- 2015-03-13
- Firm location
- Broomfield, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.