Severity
Moderate
FDA Devices recall · Reported January 21, 2015
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.
Biomet Spine, LLC recalled Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. … - a moderate-severity action.
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. … was recalled by Biomet Spine, LLC in January 21, 2015. Reason: The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the…. Check the official notice for the remedy. Verify recall #Z-0982-2015 with the FDA Devices before acting.
The recall
Biomet Spine, LLC issued this moderate-severity FDA Devices recall-The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the….
Sourced from official FDA Devices enforcement records. Verify recall #Z-0982-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-0982-2015) was formally reported on January 21, 2015, with the manufacturer initiating the action on August 22, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Biomet Spine, LLC is listed as the recalling firm, operating out of Broomfield, CO. Federal records list the affected scope as 15.
The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Distributed in PR and the states of NY, AZ, TN, TX, and CA.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
15
Related Recalls
6
3 from same agency
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.
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.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0982-2015 |
| Date reported | January 21, 2015 |
| Date initiated | August 22, 2013 |
| Recalling firm | Biomet Spine, LLC |
| Firm location | Broomfield, CO |
| Affected scope | 15 |
| Distribution | Distributed in PR and the states of NY, AZ, TN, TX, and CA. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 21, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.