FDA Medical devices recall ·
Embrace Drill Tower, Standard/Lateral (25mm) recall
- Recall number
- Z-1652-2026
- Date
- (initiated February 11, 2026)
- Company / brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
Ost Str. 4-10, Norderstedt, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 74 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
States: Alabama Arizona Florida Georgia Illinois Indiana Kansas Kentucky Louisiana Michigan North Carolina Ohio Oklahoma Texas Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1652-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.