Device product
General Manual surgical instrument
Z-2493-2021
Product summary
- Firm
- M.D.L. S.r.l.
- Event
- Event 88430
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4120 units
- Official record key
device-enforcement:Z-2493-2021
Official wording
Reason: Sterility assurance may be compromised.
Code information: Model MGC1413, Lot Numbers: 0817A Model MGC1825, Lot Numbers: 0817A Model MGP1410, Lot Numbers: 5216C Model MGP1412, Lot Numbers: 5216C Model MGP1612, Lot Numbers: 5216C Model MGP1820, Lot Numbers: 5216C Model MGP1825, Lot Numbers: 0817A Model PC1610, Lot Numbers: 3620D Model PC1810, Lot Numbers: 3620D Model PC1815, Lot Numbers: 1217B Model PM14075, Lot Numbers: 5216C Model PM1410, Lot Numbers: 3620D Model PM14114, Lot Numbers: 5216C Model PM1415, Lot Numbers: 5216C Model PM16075, Lot Numbers: 5216C Model PM1610, Lot Numbers: 3620D Model PM16114, Lot Numbers: 5216C Model PM1615, Lot Numbers: 5216C Model PM18075, Lot Numbers: 5216C Model PM18114, Lot Numbers: 5216C Model PM1815, Lot Numbers: 5216C Model VE1410, Lot Numbers: 3620D Model VES1825, Lot Numbers: 1417A
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Sterility assurance may be compromised.