FDA recall Z-1250-2018

Stryker Instruments Div. of Stryker Corporation · Class II · device

Product

1. AutoPlex System, Product Number: 0605-887-000, UDI: (01)4546540593108; 2. AutoPlex System: w/ VertaPlex HV, Product Number: 0607-687-000, UDI: (01)7613252039259 Bone cement.

Reason for recall

Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.

Distribution

Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

Key facts

Status: Terminated
Initiation date: 2017-11-09
Report date: 2018-04-04
Termination date: 2019-04-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1250-2018