FDA Recall Open, Classified

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

Recall: Z-1652-2026 · Initiated February 11, 2026

Recall

Recall Number
Z-1652-2026
Event Number
98431
Firm
Waldemar Link GmbH & Co. KG (Mfg Site) Ost Str. 4-10 Norderstedt Germany
FEI Number
3003386935
Product Code
HTW
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
February 11, 2026
Posted
March 27, 2026

Description

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.

Action

On February 11, 2026 "URGENT: MEDICAL DEVICE CORRECTION" letters were emailed to customers. Actions to be taken: Please take note of the correction of the Surgical Technique noted in section 2. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.

Distribution

US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA

Quantity

74 units