Recall Ledger

Embrace Drill Tower recall (Waldemar Link GmbH & Co. KG (Mfg Site))

Medical deviceClass IIOngoing

Summary: Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;. Reason: 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.

What is being recalled

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

Why

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.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA (states named: Alabama, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, North Carolina, Ohio, Oklahoma, Texas, Virginia)

How to tell if yours is affected

Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

Recall numberZ-1652-2026
CategoryMedical device
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedFebruary 11, 2026
ReportedApril 1, 2026
CompanyWaldemar Link GmbH & Co. KG (Mfg Site)
Company locationNorderstedt, Germany
Initiated byVoluntary: Firm initiated
Quantity74 units

More recalls from Waldemar Link GmbH & Co. KG (Mfg Site) · all medical device recalls · recalls from February 2026

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