Recall Z-1652-2026— Waldemar Link GmbH & Co. KG (Mfg Site)
Class II · Ongoing
Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2026-02-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;. Reason: 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..
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-11
- Firm location
- Norderstedt, Germany
Product description
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.