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.
This recall has been terminated (originally issued February 9, 2015).
- Company
- Biomet Spine Llc.
- Recall Initiated
- February 22, 2012
- Posted
- February 9, 2015
- Terminated
- March 23, 2015
- Recall Number
- Z-1069-2015
- Quantity
- 213
- Firm Location
- Broomfield, CO
- Official Source
- View on FDA website ↗
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.
Distribution
Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.
Lot / Code Info
Model #8734-2XXX, 8734-5XXX. Lot #L556219. Product Code: 8734-2060, CC Blade, 60mm 8734-2070, CC Blade, 70mm 8734-2080, CC Blade, 80mm 8734-2090, CC Blade, 90mm 8734-2100, CC Blade, 100mm 8734-2110, CC Blade, 110mm 8734-2120, CC Blade, 120mm 8734-2130, CC Blade, 130mm 8734-2140, CC Blade, 140mm 8734-2150, CC Blade, 150mm 8734-2160, CC Blade, 160mm 8734-2170, CC Blade, 170mm 8734-2180, CC Blade, 180mm 8734-5050, Posterior Blade, 50mm 8734-5060, Posterior Blade, 60mm 8734-5070, Posterior Blade, 70mm 8734-5080, Posterior Blade, 80mm 8734-5090, Posterior Blade, 90mm 8734-5100, Posterior Blade, 100mm 8734-5110, Posterior Blade, 110mm 8734-5120, Posterior Blade, 120mm 8734-5130, Posterior Blade, 130mm 8734-5140, Posterior Blade, 140mm 8734-5150, Posterior Blade, 150mm 8734-5160, Posterior Blade, 160mm 8734-5170, Posterior Blade, 170mm 8734-5180, Posterior Blade, 180mm
Root Cause
Nonconforming Material/Component
Action Taken
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.