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Recall Observatory FDA recall evidence

Device product

TLS2 Thermal Ligating Shears, Catalog Number 132-131D

Z-1698-2019

March 22, 2019

Class II

Product summary

Firm
Microline Surgical, Inc.
Event
Event 82708
Status
Terminated
Classification
Class II
Quantity
115 units
Official record key
device-enforcement:Z-1698-2019

Official wording

Reason: The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.

Code information: UDI: 811099011439; Lot Numbers: 807118, 807119, 807120, 811076

Distribution pattern: The products were distributed to the following US states: ND and NY. The products were distributed to the following foreign countries: Germany, Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The shears exhibited a high rate of complete or intermittent failure to actuate. As a result, they do not perform their intended function in surgical procedures.