Device product
Total Joint Pack, part number 006358-6
Z-1374-2017
Product summary
- Event
- Event 76280
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 kits
- Official record key
device-enforcement:Z-1374-2017
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 84847, 2/28/2017 87391, 3/31/2017 89385, 6/17/2017 89960, 6/8/2017 94833, 6/26/2017 97859, 6/23/2017
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
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.