FDA Device recall Z-0982-2015
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102
- FDA Device
- Class II
- terminated
- Published 2015-01-21
On 2015-01-21 the FDA classified a Class II recall of Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102 by Biomet Spine, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0982-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-22 |
| Published | 2015-01-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Biomet Spine |
| Distribution | AZ, CA, NY, PR, TN, TX |
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.
Identifiers
| code_info | Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0982-2015%22
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