Recall Z-2759-2015 ยท KWP Appliance, Fixation, Spinal Interlaminal
Biomet Spine, LLC
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 u
| Date | Sep 10, 2015 (initiated Jul 22, 2015) |
| Status | Terminated |
| 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. |
| Root cause | 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 Interlocke |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122378 | NEXTGEN ALTIUS OCT SYSTEM Biomet Spine (Aka Ebi, LLC), Sep 20, 2012 |