FDA recall Z-2160-2019

Product

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

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

Key facts

Status

Terminated

Initiation date

2019-06-18

Report date

2019-08-14

Termination date

2020-05-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allendale, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2160-2019