FDA-Device2026-04-01Class IIMISBRANDING
Waldemar Link Embrace Drill Tower surgical instructions contain incorrect article numbers
What this means
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.
- Locate your Embrace Drill Tower instruction manual (Item 645-081/62 or 645-081/63)
- Review the individual surgical steps, which are accurate
- Disregard article numbers listed in the equipment overview section
- Contact Waldemar Link or your distributor for a corrected manual
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
74 units
Manufactured in
Ost Str. 4-10, Norderstedt, Germany
Products
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1652-2026Want us to check the next one for you?
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