Z-2160-2019 Class II Terminated
FDA device recall Z-2160-2019 was initiated by Howmedica Osteonics Corp. on June 18, 2019 and is designated Class II. 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 require… The recall status is terminated (terminated May 22, 2020). Affected quantity: 11.
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