Reported Jun 25, 2014 · Terminated
Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
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 · 399 Jefferson Rd · Parsippany, NJ · 07054-3707
Is this the product you have?
- Biomet Spine, Cypher MIS Screw Inserter, Catalog number 14-501669, instrument for Spinal Screw Fixation System.
- Lot codes and dates
Catalog Number 14-501669Lot Number 006731
- Amount recalled
- 32 units (30 domestic and 2 international)
Where it was sold
- Nationwide
Why it was recalled
The Cypher MIS Screw Inserter may exhibit an increased rate of instrument tip failure.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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