Recall Z-1258-2024— Waldemar Link GmbH & Co. KG (Mfg Site)
Class II · Ongoing
Class II FDA medical device recall by Waldemar Link GmbH & Co. KG (Mfg Site), initiated 2024-01-29. FDA's recall record names no specific 510(k) clearance for this event. Product: Embrace Drill Tower, Standard/Lateral (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..
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-29
- Firm location
- Norderstedt, Germany
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.