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Terminated

Timberline Cranial Caudal and Posterior Blades, 40 - 180mm Model # 8734-2XXX, 8734-5XXX is a reusable device provided within an aluminum sterilization tray along with other instruments for use in a Timberline procedure Timberline Anchored Lateral Retractable Drills are used with the Timberline Lateral System to establish access into the vertebrae for the screws utilized to anchor the plate to the vertebrae.

FDA Recall Z-1069-2015 · Posted 2015-02-09

Recalling FirmBiomet Spine, LLC
Recall StatusTerminated
Product CodeMAX
Date Initiated2012-02-22
Date Terminated2015-03-23
Product Quantity213

Reason for Recall

Biomet Spine, LLC is recalling the Timberline Cranial Caudal and Posterior Blades, 40-180mm due to oversize of the set screw hex feature.

Firm Action

Biomet initiated the recall on February 22, 2012, No letters were or will be sent to customers. 100% retrieval was achieved by working directly with the customers. For questions regarding this recall call 303-501-8548.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.

Official Source

View FDA Recall →

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

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