FDA Enforcement
Class II
Ongoing
Embrace Drill Tower, Wedged (25mm)
Recall: Z-1257-2024
·
Reported March 13, 2024
Enforcement
- Recall Number
- Z-1257-2024
- Event ID
- 93979
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Report Date
- March 13, 2024
- Initiation Date
- January 29, 2024
- Classification Date
- March 6, 2024
- Address
- Oststr. 4-10, Norderstedt, N/A, Germany
Description
Embrace Drill Tower, Wedged (25mm)
Reason
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.
Code Info
Item Number: 645-081/62; UDI/DI: 04026575534715; All lots of the LINK Embrace Drill Tower surgical instruments.
Distribution
US Nationwide distribution in the states of AL and LA.
Quantity
6 units