FDA Device recall Z-0276-2017
Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room
- FDA Device
- Class II
- terminated
- Published 2016-10-26
On 2016-10-26 the FDA classified a Class II recall of Total Joint Pack, Kit number 006358-5 and 006358-6 convenience custom kits used for general surgery in hospital operating room 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-0276-2017 |
| 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
Total Joint Pack, Kit number 006358-5 and 006358-6 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: 58057 5/6/2014 58493 5/30/2014 61598 7/28/2014 59008 8/21/2014 60647 8/31/2014 625…Lot Number/ Expiration Date: 58057 5/6/2014 58493 5/30/2014 61598 7/28/2014 59008 8/21/2014 60647 8/31/2014 62544 1/16/2015 63813 2/28/2015 66309 4/13/2015 67352 11/1/2015 73747 3/1/2016 77176 6/17/2016 56393 7/3/2016 79087 8/31/2016 |
|---|
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-0276-2017%22
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