Reported Jul 29, 2015 · Terminated
Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF…
Biomet Spine, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Biomet Spine, LLC · 399 Jefferson Rd · Parsippany, NJ · 07054-3707
Is this the product you have?
- 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.
- Lot codes and dates
- Part Numbers
14-58202014-58202214-58202514-58203014-58203514-58204014-58212014-58212214-58212514-58212714-58213014-58213514-58214014-58222014-58222214-58222514-58223014-58223514-58224014-58224514-58225014-59232014-58232514-58233014-58233514-58234014-58234514-58235014-58253014-58253514-58254014-58254514-58255014-58256514-58257014-58257514-58302014-58302514-58303014-58303514-58304014-58312014-58312514-58313014-58313514-58314014-58322014-58322514-58323014-58323514-58324014-58324514-58325014-58332014-58332514-58333014-58333514-58334014-583345 and 14-583350. All lots
- Part Numbers
- Amount recalled
- 4,765 units
Where it was sold
Why it was recalled
Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification.
This product could cause temporary or reversible health problems — stop using it.
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