FDAFDA · Food and drugs·Recall number Z-1260-2017
Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C
Published March 8, 2017 · Recall initiated: January 11, 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
The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Windstone Medical Packaging, Inc.
- Distributor
- Distributed in AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NE, NJ, NV, OH, PA, TX, UT, VA, and WA.
- Lot
- Lot numbers and Expiration dates: 84343, 5/20/2018 88052, 11/11/2018 89579, 11/15/2018 89709, 12/10/2018 94934, 1/4/2019 95441, 6/3/2019
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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