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Recall Observatory FDA recall evidence

Device product

Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.

Z-0690-2016

December 15, 2015

Class II

Product summary

Firm
Globalmed Logistix
Event
Event 72904
Status
Terminated
Classification
Class II
Quantity
118 units
Official record key
device-enforcement:Z-0690-2016

Official wording

Reason: The cannulae may bend during procedure.

Code information: Ref # AR1318, Lot AB 0643 and AB 0732. Expiration date 04/2020.

Distribution pattern: CA, CO, CT, FL, GA, NJ and NY.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The cannulae may bend during procedure.