FDA-Device2026-04-01Class IIMISBRANDING
Waldemar Link Embrace Drill Tower recalled for incorrect article numbers in surgical guide
What this means
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.
- If you use this device, verify article numbers in your surgical technique manual against the actual instruments before surgery
- Contact your Waldemar Link distributor or the manufacturer for a corrected surgical technique guide
- Follow the individual surgical steps as written—they are accurate
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Affected count
75 units
Manufactured in
Ost Str. 4-10, Norderstedt, Germany
Products
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1651-2026Want us to check the next one for you?
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