Z-2160-2019 Class II Terminated

Recalled by Howmedica Osteonics Corp. — Allendale, NJ

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
June 18, 2019
Termination Date
May 22, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11

Product Description

Serrato 9.5mm X 90mm Polyaxial Screw Catalog Number 482619590 Serrato 9.5mm X 100mm Polyaxial Screw Catalog Number 4826195100

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.

Distribution Pattern

US Nationwide Distribution - CA, FL, GA, MA, NY, PA, TX

Code Information

Lot # B88751 UDI: (01)07613327351576(11)190125(10)B88751