FDA-Device2019-08-14Class II
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Howmedica Osteonics Corp.
Hazard
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.
Sold states
US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
Affected count
11
Manufactured in
2 Pearl Ct, N/A, Allendale, NJ, United States
Products
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2019Don't want to check this manually?
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