Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;

FDA device recall Z-1651-2026 · posted 2026-03-27 · Open, Classified

Recall details

Recalling firm

Waldemar Link GmbH & Co. KG (Mfg Site)

Reason for recall

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 taken

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 complaints@linkbio.com for any questions.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HTW

Quantity affected

75 units

Distribution

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

Date initiated

2026-02-11

Date posted

2026-03-27

Location

Norderstedt, Germany