Reported Mar 27, 2013 · Terminated
Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a…
Ebi, 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: Ebi, Llc · 100 Interpace Pkwy · Parsippany, NJ · 07054-1149
Is this the product you have?
- Biomet Spine Polaris 5.5 Button Lock Screw Inserter. Catalog Number 14-500178. The Polaris Spinal System is a non-cervical, pedicle screw spinal fixation device.
- Lot codes and dates
- Catalog Number 14-500178
- Lot numbers
543619543853543853-1543853-2544233544234-1546613 and 546613-1
- Amount recalled
- 59 units.
Where it was sold
Why it was recalled
Increased risk of failure at the driver tip during screw insertion or removal.
This product could cause temporary or reversible health problems — stop using it.
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