FDA-Device2026-04-01Class IIMISBRANDING
Waldemar Link Embrace Drill Tower recalled for incorrect article numbers in surgical guide
Check Embrace Drill Tower documentation
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
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.
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-1651-2026More Waldemar Link GmbH & Co. KG (Mfg Site) recalls
- FDA-Device2026-04-01Waldemar Link Embrace Drill Tower surgical instructions contain incorrect article numbers
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau recalled for potential bushing detachment
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau screw recalled for detaching bushing
- FDA-Device2026-03-18Waldemar Link Endo-Model SL Connection Component recalled for potential bushing detachment
- FDA-Device2026-03-18Waldemar Link Endo-Model Replacement Plateau screw recalled for potential bushing detachment
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