Waldemar Link GmbH & Co. KG (Mfg Site) recalls Embrace Drill Tower
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Embrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Lot / code information
- Part / Item #
- 645-081/62
- UDI
- 04026575534715
- Lot #
- All Lots
What the firm is doing
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.
DistributionShow detailsHide
US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-1652-2026
- FDA device classification · HTWOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.4540The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Waldemar Link GmbH & Co. KG (Mfg Site)Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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