Reported Aug 14, 2019 · Terminated
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number…
Howmedica Osteonics Corp.
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: Howmedica Osteonics Corp. · 2 Pearl Ct · Allendale, NJ · 07401-1611
Is this the product you have?
- Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
- Lot codes and dates
- Lot #
- B88751 UDI(01)07613327351576(11)190125(10)B88751
- Amount recalled
- 11
Where it was sold
Why it was recalled
Discrepant length; Lot B88751 90mm screws were manufactured with a 100mm length instead of the required 90mm length; lot B90243 100mm screws were manufactured with a 90mm length instead of the required 100mm length.
This product could cause temporary or reversible health problems — stop using it.
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