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AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06...

FDA Recall #Z-0626-2016 — Class II — December 8, 2015

Recall #Z-0626-2016 Date: December 8, 2015 Classification: Class II Status: Terminated

Product Description

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.

Reason for Recall

The trial shell mating feature on the broach is undersized.

Recalling Firm

Encore Medical, Lp — Austin, TX

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

23 units

Distribution

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

Code Information

178881L05, 178881L06, 183345L03, 178881L09, 178881L10, 183345L05, 178881L11, 178881L12, 183345L06

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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