FDAFDA · Food and drugs·Recall number Z-1249-2018
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Published April 4, 2018 · Recall initiated: November 9, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Distributor
- 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.
- Lot
- Lot Number: 17277012 UDI: (01)4546540907035
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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