Recall Z-2152-2015
Biomet Spine, LLC · initiated March 12, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Part Numbers: 14-582020, 14-582022, 14-582025, 14-582030, 14-582035, 14-582040, 14-582120, 14-582122, 14-582125, 14-582127, 14-582130, 14-582135, 14-582140, 14-582220, 14-582222, 14-582225, 14-582230, 14-582235, 14-582240, 14-582245, 14-582250, 14-592320, 14-582325, 14-582330, 14-582335, 14-582340, 14-582345, 14-582350, 14-582530, 14-582535, 14-582540, 14-582545, 14-582550, 14-582565, 14-582570, 14-582575, 14-583020, 14-583025, 14-583030, 14-583035, 14-583040, 14-583120, 14-583125, 14-583130, 14-583135, 14-583140, 14-583220, 14-583225, 14-583230, 14-583235, 14-583240, 14-583245, 14-583250, 14-583320, 14-583325, 14-583330, 14-583335, 14-583340, 14-583345 and 14-583350. All lots.
Reason for recall
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
FDA-determined cause: Nonconforming Material/Component
Action taken
Biomet Spine issued an Urgent Medical Device Recall Notice/Response Form dated 3/12/2015 to their affected customers.
Details
- Recall number
- Z-2152-2015
- Initiated
- March 12, 2015
- Posted by FDA
- July 20, 2015
- Terminated
- December 21, 2015
- Product code
- NKB – Thoracolumbosacral Pedicle Screw System
- 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.
- Recalling firm
- Biomet Spine, LLC, Parsippany, NJ