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U.S. Department of Health and Human Services

Class 2 Device Recall Timberline Retractor Blade

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  Class 2 Device Recall Timberline Retractor Blade see related information
Date Initiated by Firm February 22, 2012
Date Posted February 09, 2015
Recall Status1 Terminated 3 on March 23, 2015
Recall Number Z-1069-2015
Recall Event ID 70381
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product 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.
Code Information 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
Recalling Firm/
Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact Mike Medina
Manufacturer 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.
FDA Determined
Cause 2
Nonconforming Material/Component
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.
Quantity in Commerce 213
Distribution Distributed to TX, IN, MO, and NY. No foreign/govt/military/VA.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.