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Recall Observatory FDA recall evidence

Device product

Turbett Surgical Container, TS1500

Z-1501-2022

April 14, 2022

Class II

Product summary

Firm
Turbett Surgical, Inc.
Event
Event 90578
Status
Terminated
Classification
Class II
Quantity
7 units
Official record key
device-enforcement:Z-1501-2022

Official wording

Reason: Devices were subject to unapproved rework processes.

Code information: UDI-DI (GTIN): 00859464007113; Lot No./Serial No.: 100036/2017061015, 100036/2017061016, 100036/2017061017, 100036/2017061019, 100036/2017061023, 100036/2017061025, 100065/2017121001 and 100081/2018031004.

Distribution pattern: US Nationwide Nationwide: CO, FL, NC and PA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Devices were subject to unapproved rework processes.