FDAFDA · Food and drugs·Recall number Z-1258-2024
Embrace Drill Tower, Standard/Lateral (25mm)
Published March 13, 2024 · Recall initiated: January 29, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Distributor
- US Nationwide distribution in the states of AL and LA.
- Lot
- Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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