Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-1250-2018

Z-1250-2018 Class II Terminated

Recalled by Stryker Instruments Div. of Stryker Corporation — Portage, MI

Recall Details

Product Type
Devices
Report Date
April 4, 2018
Initiation Date
November 9, 2017
Termination Date
April 16, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1244

Product Description

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 Pattern

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.

Code Information

1. Lot Number: 17278012; 2. Lot Numbers: 17278012, 17278022, 17279022, 17282012, 17282022, 17291012, 17291022 UDI: (01)4546540593108; (01)7613252039259

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