Exactech, Inc.: Equinoxe Humeral Stem, Primary, Press Fit, 11mm

Is my product affected?

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

• UPC 10885862079312

Check against the official notice below — it lists the full affected range.

What happened

Exactech, Inc. is recalling 14 Equinoxe Humeral Stem, Primary, Press Fit, 11mm devices due to incorrect Instructions For Use included in the product packages. The affected devices were distributed in the United States to Kansas, Ohio, and California, as well as internationally to Australia and Germany. The recalled devices are identified by Catalog Number 300-01-11, Packaging Lot 49088921, and serial numbers 6477393 through 6477407.

The recall notice does not specify a remedy or recommended action for consumers who may have received or used these devices.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.

Details from the source

Reason for recall: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. Distribution: Distributed within the US to KS, OH, CA. International distribution to Australia and Germany. Quantity: 14 devices Lot/code info: Catalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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