Moderate riskFDA DeviceClass II

Waldemar Link Embrace Drill Tower surgical instructions contain incorrect article numbers

The surgical instruction guide for the Waldemar Link Embrace Drill Tower shoulder instrument contains mixed-up article numbers in the equipment overview section. The individual surgical steps themselves are correct and safe to follow.

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

What to do

  1. Locate your Embrace Drill Tower instruction manual (Item 645-081/62 or 645-081/63)
  2. Review the individual surgical steps, which are accurate
  3. Disregard article numbers listed in the equipment overview section
  4. Contact Waldemar Link or your distributor for a corrected manual

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
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
74 units
Illnesses reported
None reported
Manufactured in
Ost Str. 4-10, Norderstedt, Germany
Classification
Class II
Recall number
Z-1652-2026

In the FDA's words

Description
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63; 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: 74 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.

More from Waldemar Link

See all

Related topics