Recall Z-2152-2015 ยท NKB Thoracolumbosacral Pedicle Screw System
Biomet Spine, LLC
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component.
| Date | Jul 20, 2015 (initiated Mar 12, 2015) |
| Status | Terminated |
| Reason | Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. |
| Root cause | Nonconforming Material/Component |
| Action | Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers. |
| Quantity | 4,765 units |
| Distribution | Distribution US Nationwide (AL, CA, CO, FL, GA, LA, MA, MD, MI, MO, NY, OH, PA, TX, WA, WI) and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133746 | POLARIS SPINAL SYSTEM Biomet Spine (Aka Ebi, LLC), Mar 12, 2014 |