FDA-Device2026-04-01Class II
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Waldemar Link GmbH & Co. KG (Mfg Site)
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-1651-2026Original summary
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
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