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Recall Observatory FDA recall evidence

Device product

DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, REF: 533-06-108

Z-2607-2023

August 04, 2023

Class II

Product summary

Firm
Encore Medical, LP
Event
Event 92969
Status
Ongoing
Classification
Class II
Quantity
15
Official record key
device-enforcement:Z-2607-2023

Official wording

Reason: Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery

Code information: UDI-DI/Lot: 00190446259091/923W1411/April 3, 2029

Distribution pattern: US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH, PA, PR, RI, SC, TX, UT, VA, WA. OUS: Sweden, Australia, France, UK, Colombia, Germany

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery