Z-1258-2024 Class II Ongoing
FDA device recall Z-1258-2024 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on Jan 29, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 6 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 13, 2024
- Initiation Date
- Jan 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units
Product Description
Embrace Drill Tower, Standard/Lateral (25mm)
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of AL and LA.
Code Information
Item Number: 645-081/63; UDI/DI: 04026575534722; All lots of the LINK Embrace Drill Tower surgical instruments.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1258-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026