Recall Z-2152-2015— Biomet Spine, LLC
Class II · Terminated
Class II FDA medical device recall by Biomet Spine, LLC, initiated 2015-03-12, terminated 2015-12-21. It names one FDA 510(k) clearance: K133746. Product: 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.. Reason: Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification..
- Recalling firm
- Biomet Spine, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-03-12
- Terminated
- 2015-12-21
- Firm location
- Parsippany, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
Data sourced from openFDA. This site is unofficial and independent of the FDA.