United StatesEmbrace Drill Tower, Wedged (25 mm) (Item Number 645-081/62; UDI 04026575534715) and Embrace Drill Tower, Standard/Lateral (25 mm) (Item Number 645-081/63) manufactured by Waldemar Link GmbH & Co. KG and distributed in the US (AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA); all lots (75 and 74 units respectively) are affected. They were recalled because the surgical technique overview lists mixed-up article numbers, although the individual surgical steps in the technique are correct.
What's being recalled
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Recalling firm: Waldemar Link GmbH & Co. KG (Mfg Site), Norderstedt, Germany.
How to identify it
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
The 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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)