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Recall Observatory FDA recall evidence

Device product

Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219

Z-2386-2016

July 20, 2016

Class II

Product summary

Firm
Integra LifeSciences Corp.
Event
Event 74757
Status
Terminated
Classification
Class II
Quantity
495 units
Official record key
device-enforcement:Z-2386-2016

Official wording

Reason: Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.

Code information: Lot # GT0420 and GT0419

Distribution pattern: US Distribution to the states of : FL, VA, OK, CO, DC and IN.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Through the investigation of reported complaints Integra verified that there have been instances where the Universal Wire Fixation Bolts the Slotted Post broke during use at the surgical site.