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Recall Observatory FDA recall evidence

Device product

Knee Arthroscopy Pack , part number AMS2610(A Knee Arthroscopy Pack, part number AMS3236(A Knee Arthroscopy Pack, part numbre AMS3860

Z-1320-2017

January 11, 2017

Class II

Product summary

Firm
Windstone Medical Packaging, Inc.
Event
Event 76280
Status
Terminated
Classification
Class II
Quantity
700 kits
Official record key
device-enforcement:Z-1320-2017

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 number and expiration date 100023, 9/22/2019 100595, 9/1/2019 84529, 5/13/2018 84584, 5/26/2018 84728, 5/25/2018 85250, 7/22/2018 85273, 7/10/2018 85645, 8/1/2018 85845, 8/19/2018 87286, 8/11/2019 87350, 9/21/2018 87967, 9/24/2018 88173, 11/11/2018 88390, 11/21/2018 88627, 12/24/2018 89082, 10/3/2018 89422, 12/16/2018 89511, 11/13/2018 94573, 11/19/2018 94941, 11/20/2018 95452, 5/6/2019 95985, 3/8/2019 97273, 5/22/2019 98169, 6/26/2019 98664, 6/25/2019 98675, 6/23/2019 99375, 6/12/2019

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.