Waldemar Link GmbH & Co. KG recalled 75 Embrace Shoulder Drill Tower devices distributed to U.S. hospitals after discovering mixed-up article numbers in the device overview. The surgical steps are correct, but the overview labeling is inaccurate. Healthcare providers should stop using the device immediately and follow manufacturer recall instructions sent by email.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: E-Mail
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This device is part of the Embrace shoulder instrumentation used in orthopedic procedures. It is a wedged drill tower component used in shoulder surgery.
The mislabeling of article numbers could lead to incorrect instrument identification during procedures, which may compromise patient safety.
This recall is not indicated as part of a broader industry pattern in the available data.
Healthcare providers may need to verify instrument IDs before use, potentially causing procedural delays.
Recall notice and UDI can be referenced in FDA enforcement records linked to Z-1651-2026
Processing times for replacement or disposition are determined by the manufacturer and healthcare facilities
Keep copy of recall notice, email communications, and any disposition records for the device
Model/Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots; Quantity: 75 units; Distributed to: 15 US states (AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA); Sold to: Hospitals and surgical centers; Recall date: 2026-02-11; Status: Active; Manufacturer: Waldemar Link GmbH & Co. KG; Manufacturer site: Germany; Distribution: US.
No injuries or incidents have been reported.
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Waldemar Link GmbH & Co. KG recalls 74 Embrace Drill Tower devices distributed in 15 U.S. states. The recall notes mixed-up article numbers in the overview of the instruments. The surgical steps are correct. Stop using the device immediately and follow manufacturer instructions.
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