Device product
Regard, Item Number: 800553001, Sterile, OR0642A - Total Knee - Medical Center Santa Rosa
Z-1613-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 216 kits
- Official record key
device-enforcement:Z-1613-2017
Official wording
Reason: Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
Code information: 030564A Exp Date 2017-11-30; 031034A Exp Date 2017-11-30; 0318321A Exp Date 2018-01-30; 033317A Exp Date 2018-03-30;
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field