Skip to content
Recall Observatory FDA recall evidence

Device product

Anterior Cervical Fusion Pack, part number AMS2502(A Anterior Cervical Fusion Pack, part number AMS2502(C

Z-1260-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
51 kits
Official record key
device-enforcement:Z-1260-2017

Official wording

Reason: 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.

Code information: 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

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.