Device product
Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn
Z-1652-2017
Product summary
- Event
- Event 76255
- Status
- Terminated
- Classification
- Class II
- Quantity
- 496 kits
- Official record key
device-enforcement:Z-1652-2017
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: 029881B Exp Date 2017-12-04; 030864B Exp Date 2018-01-13; 032446B Exp Date 2018-3-25; 033940B Exp Date 2018-06-02
Distribution pattern: US Distribution to LA and TX.
Derived failure modes
-
Sterility assurance
breaking the sterile field