LINK Embrace Shoulder System Line Extension recallZ-1651-2026 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Feb 11, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Under Investigation by firm
What the company 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 [email protected] for any questions.
Recall details
- Recall number
- Z-1651-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 11, 2026
- Posted by the FDA
- Mar 27, 2026
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 75 units
- Product code
- HTW
- Distribution
- US distribution to states of: AL, AZ, FL, GA, IL, IN, KS, KY, LA, MI, NC, OH, OK, TX, VA
Product description
Embrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;
Code information (models, lots, serial numbers)
Item Number: Item Number: 645-081/62; UDI: 04026575534715; Lot Number: All Lots;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- LINK Embrace Shoulder System Line Extension 645-081/62WALDEMAR LINK GmbH & Co. KG · Bit, Drill3 recalls1 report
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98431).
- Z-1652-2026 · Open, ClassifiedEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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