Recall Z-2289-2025— 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 2025-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.. Reason: Inconsistent size terminology and color coding used on labeling.
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-07-15
- Firm location
- Norderstedt, N/A, Germany
Product description
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.
Reason for recall
Inconsistent size terminology and color coding used on labeling
Data sourced from openFDA. This site is unofficial and independent of the FDA.