FDA Recall 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.

Recall: Z-1069-2015 · Initiated February 22, 2012

Recall

Recall Number
Z-1069-2015
Event Number
70381
Firm
Biomet Spine, LLC
FEI Number
3012447612
Product Code
MAX
Status
Terminated
Root Cause
Nonconforming Material/Component
Initiated
February 22, 2012
Posted
February 9, 2015
Terminated
March 23, 2015
Address
310 Interlocken Pkwy, Ste 120, Broomfield, CO, 80021-3464

Description

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.

Reason

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

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.

Distribution

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

Quantity

213