Moderate riskFDA DeviceClass II

Waldemar Link Embrace Drill Tower recalled for incorrect article numbers in surgical guide

Waldemar Link's Embrace Shoulder Instruments Drill Tower (25mm, Item 645-081/62) was distributed with a surgical technique guide that lists incorrect article numbers in the instrument overview. The step-by-step surgical instructions themselves are correct and safe to follow.

From the FDA notice · Read the official notice ↗ · All Waldemar Link recalls

What to do

  1. If you use this device, verify article numbers in your surgical technique manual against the actual instruments before surgery
  2. Contact your Waldemar Link distributor or the manufacturer for a corrected surgical technique guide
  3. Follow the individual surgical steps as written—they are accurate

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Sold in
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Made for
All ages (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected
75 units
Illnesses reported
None reported
Manufactured in
Ost Str. 4-10, Norderstedt, Germany
Classification
Class II
Recall number
Z-1651-2026

In the FDA's words

Description
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62; 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. Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots; Distribution: US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA Affected quantity: 75 units
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.

2 products in this recall

Waldemar Link Embrace Drill Tower surgical technique has mixed-up article numbers

Waldemar Link is recalling two Embrace Drill Tower instruments used in shoulder surgery, 149 units in total. The surgical technique's overview lists some article numbers incorrectly, though the individual surgical steps in the technique are correct. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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