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Terminated

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.

FDA Recall Z-0982-2015 · Posted 2015-01-15

Recalling FirmBiomet Spine, LLC
Recall StatusTerminated
Product CodeOVD
Date Initiated2013-08-22
Date Terminated2015-03-13
Product Quantity15

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.

Firm Action

Distributors and Direct Sales Reps notified via letter to return product.

Root Cause

Component design/selection

Distribution Pattern

Distributed in PR and the states of NY, AZ, TN, TX, and CA.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K123767LANX FUSION SYSTEM- SALanx, Inc. · 2013-03-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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