FDA Device recall Z-0269-2017

Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits…

FDA Device
Class II
terminated
Published 2016-10-26

On 2016-10-26 the FDA classified a Class II recall of Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits… by Windstone Medical Packaging, citing the Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-0269-2017
Classification	Class II
Status	terminated
Initiated	2015-04-22
Published	2016-10-26
Last updated	2026-09-13 11:54 UTC
Company	Windstone Medical Packaging
Distribution	US

Product

Shoulder Arthroscopy Pack, Kit number 002648-15, 002648-16, AMS2496, AMS2496(A, AMS2609, PSS2209(A, and PSS2209(B. convenience custom kits used for general surgery in hospital operating room

Reason

The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.

Identifiers

code_info	Lot Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 6… Lot Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 62189 2/12/2014 57522 4/30/2014 60028 5/12/2014 60303 5/19/2014 61416 8/17/2014 63836 9/7/2014 66799 9/19/2014 61924 12/3/2014 63333 12/8/2014 65167 12/31/2014 67369 2/4/2015 68073 4/17/2015 70983 9/6/2015 70169 9/21/2015 71061 10/10/2015 65331 11/5/2015 62082 11/7/2015 66580 11/20/2015 64544 1/29/2016 68947 2/19/2016 74854 3/23/2016 75534 4/25/2016 69610 5/7/2016 71352 6/17/2016 66677 7/5/2016 67866 7/6/2016 67702 7/30/2016 77629 7/30/2016 78550 7/30/2016 68712 9/13/2016 68215 9/17/2016 79701 10/11/2016 70494 10/17/2016 75648 12/1/2016 71381 12/12/2016 76128 1/22/2017 72479 3/15/2017 72951 3/24/2017 73131 4/15/2017 74758 5/5/2017 73849 5/7/2017 73192 5/30/2017 76672 7/17/2017 80956 8/8/2017 78024 8/23/2017 77684 10/24/2017 79660 1/9/2018 78944 1/16/2018

code_info

Lot Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 6…

Lot Number/ Expiration Date: 59007 8/27/2013 57610 8/31/2013 60128 12/15/2013 62099 12/21/2013 61297 2/9/2014 62189 2/12/2014 57522 4/30/2014 60028 5/12/2014 60303 5/19/2014 61416 8/17/2014 63836 9/7/2014 66799 9/19/2014 61924 12/3/2014 63333 12/8/2014 65167 12/31/2014 67369 2/4/2015 68073 4/17/2015 70983 9/6/2015 70169 9/21/2015 71061 10/10/2015 65331 11/5/2015 62082 11/7/2015 66580 11/20/2015 64544 1/29/2016 68947 2/19/2016 74854 3/23/2016 75534 4/25/2016 69610 5/7/2016 71352 6/17/2016 66677 7/5/2016 67866 7/6/2016 67702 7/30/2016 77629 7/30/2016 78550 7/30/2016 68712 9/13/2016 68215 9/17/2016 79701 10/11/2016 70494 10/17/2016 75648 12/1/2016 71381 12/12/2016 76128 1/22/2017 72479 3/15/2017 72951 3/24/2017 73131 4/15/2017 74758 5/5/2017 73849 5/7/2017 73192 5/30/2017 76672 7/17/2017 80956 8/8/2017 78024 8/23/2017 77684 10/24/2017 79660 1/9/2018 78944 1/16/2018

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-0269-2017%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.