Waldemar Link GmbH & Co. KG (Mfg Site)
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
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.
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →