FDA Device recall Z-1368-2017

Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AM…

FDA Device
Class II
terminated
Published 2017-03-08

On 2017-03-08 the FDA classified a Class II recall of Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AM… by Windstone Medical Packaging, citing 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 sterili….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1368-2017
Classification	Class II
Status	terminated
Initiated	2017-01-11
Published	2017-03-08
Last updated	2026-09-13 11:54 UTC
Company	Windstone Medical Packaging
Distribution	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, WA

Product

Shoulder Arthroscopy Pack, part number AMS2496(A Shoulder Arthroscopy Pack, part number AMS2496(B Shoulder Arthroscopy Pack, part number AMS2496(C Shoulder Arthroscopy Pack, part number AMS2609 Shoulder Arthroscopy Pack, part number AMS3857 Shoulder Arthroscopy Pack, part numbr AMS4766 Shoulder Arthroscopy Pack, part number AMS4766(A Shoulder Arthroscopy Pack, part number AMS4766(B

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.

Identifiers

code_info	Lot number and expiration date 100823, 10/13/2019 100856, 9/5/2019 84375, 5/20/2018 84747, 7/23/2018 85059, 7/21… Lot number and expiration date 100823, 10/13/2019 100856, 9/5/2019 84375, 5/20/2018 84747, 7/23/2018 85059, 7/21/2018 85549, 7/13/2018 85838, 8/1/2018 86718, 9/5/2018 87103, 9/12/2018 87106, 9/15/2018 87277, 8/10/2019 87347, 6/22/2018 87916, 6/22/2019 87962, 11/15/2018 88047, 9/4/2018 88376, 12/29/2018 89418, 11/12/2018 94736, 1/21/2019 95273, 6/12/2019 96914, 6/15/2019 97450, 5/11/2019 98491, 9/27/2019 98503, 6/6/2019 99369, 9/27/2019

code_info

Lot number and expiration date 100823, 10/13/2019 100856, 9/5/2019 84375, 5/20/2018 84747, 7/23/2018 85059, 7/21…

Lot number and expiration date 100823, 10/13/2019 100856, 9/5/2019 84375, 5/20/2018 84747, 7/23/2018 85059, 7/21/2018 85549, 7/13/2018 85838, 8/1/2018 86718, 9/5/2018 87103, 9/12/2018 87106, 9/15/2018 87277, 8/10/2019 87347, 6/22/2018 87916, 6/22/2019 87962, 11/15/2018 88047, 9/4/2018 88376, 12/29/2018 89418, 11/12/2018 94736, 1/21/2019 95273, 6/12/2019 96914, 6/15/2019 97450, 5/11/2019 98491, 9/27/2019 98503, 6/6/2019 99369, 9/27/2019

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1368-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.