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Recall Observatory FDA recall evidence

Device 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.

Z-0982-2015

August 22, 2013

Class II

Product summary

Firm
Biomet Spine, LLC
Event
Event 70056
Status
Terminated
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-0982-2015

Official wording

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.

Code information: Model 8630-0102 Anchored Lateral Retractable Drill lot TU00049: February 25, 2013 and TU00155: July 31, 2013

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.