LINK Embrace Shoulder System Line Extension recallZ-1258-2024 · Waldemar Link GmbH & Co. KG (Mfg Site) · initiated Jan 29, 2024
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 techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
FDA root cause category: Under Investigation by firm
What the company is doing
LinkBio Corp issued Urgent: Medical Device Correction letter via email on 2/8/24 to Distributors. Letter states reason for recall, health risk and action to take: Please take note of the correction of the Surgical Techniques 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-1258-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 29, 2024
- Posted by the FDA
- Mar 6, 2024
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Quantity
- 6 units
- Product code
- HTW
- Distribution
- US Nationwide distribution in the states of AL and LA.
Product description
Embrace Drill Tower, Standard/Lateral (25mm)
Code information (models, lots, serial numbers)
Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
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 645-081/63WALDEMAR LINK GmbH & Co. KG · Bit, Drill1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 93979).
- Z-1257-2024 · Open, ClassifiedEmbrace Drill Tower, Wedged (25mm)
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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