Anchored Lateral Retractable Drill — Class II medical device recall Z-0982-2015
Terminated recall by Biomet Spine, LLC, reported 2015-01-21, distributed in AZ, CA, NY, PR, TN, TX. The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the
| Recall number | Z-0982-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet Spine, LLC, Broomfield, CO, United States |
| Recall initiated | 2013-08-22 |
| Classified | 2015-01-15 |
| Reported by FDA | 2015-01-21 |
| Terminated | 2015-03-13 |
| Distributed | AZ, CA, NY, PR, TN, TX |
| Quantity | 15 |
| Lot numbers | TU00049, TU00155 |
| Model numbers | 8630-0102 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0982-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.