Reported Jan 20, 2016 · Terminated
AltiVate Reverse Humeral Broach, Size 10 Catalog number 804-06-040, Size 14 Catalog number 804-06-044, and Size 16…
Encore Medical, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Encore Medical, Lp · 9800 Metric Blvd · Austin, TX · 78758-5445
Is this the product you have?
- 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.
- Lot codes and dates
178881L05178881L06183345L03178881L09178881L10183345L05178881L11178881L12183345L06
- Amount recalled
- 23 units
Where it was sold
Why it was recalled
The trial shell mating feature on the broach is undersized.
This product could cause temporary or reversible health problems — stop using it.
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