FDA DeviceClass IINotable

FDA Recall: Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;

Date: 2026-04-01
Brand: Waldemar Link GmbH & Co. KG (Mfg Site)
Category: Medical Device
FDA Class: Class II

Description

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Hazard

The surgical technique for the Embrace Shoulder Instruments - Drill Tower has mixed-up article numbers in the overview of the instruments. However, the individual surgical steps described in the surgical technique are correct.

Remedy

74 units

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