Home / Recalls / Medical Devices
Howmedica Osteonics Corp. recalls Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 48
Recalled August 14, 2019 · FDA recall Z-2160-2019 · Howmedica Osteonics
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. · FDA Class II
Units
11
Sold at
US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
Description
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.
Product
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Manufacturer(s)
Howmedica Osteonics Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →