Recall Z-2759-2015
Biomet Spine, LLC · initiated July 22, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
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: Device Design
Action taken
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.
Details
- Recall number
- Z-2759-2015
- Initiated
- July 22, 2015
- Posted by FDA
- September 10, 2015
- Terminated
- December 10, 2015
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 49
- Distribution
- Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
- Recalling firm
- Biomet Spine, LLC, Broomfield, CO