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 Cata…
- Recall date
- December 8, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0626-2016
- FDA classification
- Class II
- Brand / firm
- Encore Medical, Lp
- Sold / distributed
- Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
Why it was recalled
The trial shell mating feature on the broach is undersized.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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.
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