Howmedica Osteonics Corp.: Medical Device Recall in 2019 - (Recall #: Z-2160-2019)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2019.
Data Source: FDA.
Product Description:
Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100
Product Classification:
Class II
Date Initiated: June 18, 2019
Date Posted: August 14, 2019
Recall Number: Z-2160-2019
Event ID: 83345
Reason for Recall:
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.
Status: Terminated
Product Quantity: 11
Code Information:
Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751
Distribution Pattern:
US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX
Voluntary or Mandated:
Voluntary: Firm initiated