Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany Embrace Drill Tower, Standard/Lateral (25mm) Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Embrace Drill Tower, Standard/Lateral (25mm)
Brand
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
Lot Codes / Batch Numbers
Item Number: 645-081/63, UDI/DI: 04026575534722, All lots of the LINK Embrace Drill Tower surgical instruments.
Products Sold
Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany is recalling Embrace Drill Tower, Standard/Lateral (25mm) due to The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" v. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 complaints@linkbio.com for any questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026