Device 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.
Z-2759-2015
Product summary
- Event
- Event 71877
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49
- Official record key
device-enforcement:Z-2759-2015
Official wording
Reason: 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.
Code information: P/N 14-525050 Lot Number 001219 P/N 14-525057 Lot Number 001220
Distribution pattern: Worldwide Distribution: US (nationwide) in states of: NY, MO, WI, IN, CA, NC, and OH, and to countries of: Japan and Netherlands.
Derived failure modes
-
Unknown
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.