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Recall Observatory FDA recall evidence

Device product

General Manual surgical instrument

Z-2493-2021

August 05, 2021

Class II

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

    reason.no_named_rule · v1.0.0

    Sterility assurance may be compromised.