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.
Reported: January 20, 2016 Initiated: December 8, 2015 #Z-0626-2016
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.
Details
- Recalling Firm
- Encore Medical, Lp
- Units Affected
- 23 units
- Distribution
- Throughout the US to the states: FL, PA, ID, CA, OH, AZ, TN, NV, WA, MS, GA, MA, KS, TX
- Location
- Austin, TX
Frequently Asked Questions
What product 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.. Recalled by Encore Medical, Lp. Units affected: 23 units.
Why was this product recalled? ▼
The trial shell mating feature on the broach is undersized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 20, 2016. Severity: Moderate. Recall number: Z-0626-2016.
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