Home / Recalls / Stryker Instruments Div. of Stryker Corporation / Z-1249-2018

Z-1249-2018 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
12

Product Description

PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.

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

Lot Number: 17277012 UDI: (01)4546540907035

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