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Recall Observatory FDA recall evidence

Device product

Large Buttress Compression Nut For Blade Guide Sleeve TFN The Synthes Large Buttress Compression Nut For Blade Guide Sleeve TFN is intended to treat stable and unstable pertrochanteric fractures, intertrochanteric fractures, basal neck fractures, and combinations there of.

Z-0387-2014

July 31, 2013

Class II

Product summary

Firm
Synthes USA HQ, Inc.
Event
Event 66421
Status
Terminated
Classification
Class II
Quantity
135
Official record key
device-enforcement:Z-0387-2014

Official wording

Reason: The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.

Code information: Part # Lot # SD357.371 5734551 6083065 6538811 6631975 6703191 6703190 6841538

Distribution pattern: US Distribution including the states of TX, PA, NY, GA, CO, IN, AI, AR, IL, MI, TN, CA, AZ, MS and VA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Large Buttress Compression Nut For Blade Guide Sleeve TFN was recalled because of complaints that the compression nut did not thread completely onto the blade guide sleeve and became stuck.