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U.S. Department of Health and Human Services

Class 2 Device Recall Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft

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  Class 2 Device Recall Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft see related information
Date Initiated by Firm July 22, 2015
Date Posted September 10, 2015
Recall Status1 Terminated 3 on December 10, 2015
Recall Number Z-2759-2015
Recall Event ID 71877
510(K)Number K122378  
Product Classification Appliance, fixation, spinal interlaminal - Product Code KWP
Product Biomet Spine Lineum OCC Starter Flexible and Lineum Flexible Inner Shaft, Model Numbers 14-525050 and 14-525057, reusable devices distributed with bubble wrap inside a plastic pouch.

The Lineum system is designed to facilitate reconstruction of the cervical and upper thoracic spine using bone screws, locking plugs, and various types of rods, hooks, and lateral connectors. One of the instruments used with this system is the Lineum Occipital Screw Starter with the inner shaft subassembly. The system comes with a fixed shaft Lineum Occipital Screw Driver, and a 90¿ driver in order to retain and drive the screw into the occipital bone.
Code Information P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
Recalling Firm/
Manufacturer		 Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information Contact Mike J. Medina
303-443-7500 Ext. 244
Manufacturer Reason
for Recall		 Biomet has initiated a recall on Biomet Spine Lineum OCC Starter Flexible and its inner shaft instrumentsafter identifying that these instruments were distributed prior to completion of all design control activities.
FDA Determined
Cause 2		 Device Design
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter dated 7/23/2015 to their Consignees/Customers via certified letter. The letter described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of device; remove from circulation; carefully follow instructions on enclosed "Response Form" and complete and return via fax to 303.501.8444; if you have further distributed these devices to medical facilities, you MUST notify them of this action; and return device and form to Zimmer Biomet Spine, 310 Interlocken Pkwy, Ste 120, Broomfield, CO 80021. Questions related to this notice should be directed to the Quality Engineer at 303-501-8457 Monday through Friday, 8 a.m. to 5 p.m. MST.
Quantity in Commerce 49
Distribution Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
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.
510(K) Database 510(K)s with Product Code = KWP and Original Applicant = BIOMET SPINE (AKA EBI, LLC)
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