Device product
DeRoyal KNEE ARTHROSCOPY PACK, REF 89-6192.04, 1 Per Pack, Distributed by: DeRoyal Industries, Inc.; Manufacturer: DeRoyal Industries, Inc.
Z-2124-2014
Product summary
- Event
- Event 68744
- Status
- Terminated
- Classification
- Class II
- Quantity
- 128 units
- Official record key
device-enforcement:Z-2124-2014
Official wording
Reason: The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.
Code information: Lot Numbers: 30674381, 30721925, 30733281, 31029711, 31442590, 31649363
Distribution pattern: Distributed in the states of MI, GA, OH, IL, MO, and IN.
Derived failure modes
-
Unknown
The firm distributed surgical kits which contained Irrigation Sets which were subsequently recalled by Hospira.