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Recall Observatory FDA recall evidence

Device product

AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catalog number 804-06-046. Orthopedic surgical instrument for use with Encore Shoulder prosthesis.

Z-0626-2016

December 08, 2015

Class II

Product summary

Firm
Encore Medical, Lp
Event
Event 72809
Status
Terminated
Classification
Class II
Quantity
23 units
Official record key
device-enforcement:Z-0626-2016

Official wording

Reason: The trial shell mating feature on the broach is undersized.

Code information: 178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06

Distribution pattern: Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The trial shell mating feature on the broach is undersized.