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Encore Medical, Lp recalls AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16 Catal
Recalled January 20, 2016 · FDA recall Z-0626-2016 · Encore Medical
Hazard
The trial shell mating feature on the broach is undersized. · FDA Class II
Units
23 units
Sold at
Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
Description
The trial shell mating feature on the broach is undersized.
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.
Manufacturer(s)
Encore Medical, Lp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →