Waldemar Link GmbH & Co. KG (Mfg Site) 2024-03-20 Health serious FDA
Health · FDA · Recall #FDA-Z-1299-2024
SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented Recall
Issued March 20, 2024 · Waldemar Link GmbH & Co. KG (Mfg Site)
In March 2024, Waldemar Link GmbH & Co. KG (Mfg Site) recalled the SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
What you should do
- 1 Stop using SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Waldemar Link GmbH & Co. KG (Mfg Site) to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Health
- Recall date
- March 20, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.
- Recall number
- FDA-Z-1299-2024
- Made in
- Germany
- Issuing agency
- FDA
In context
- Waldemar Link GmbH & Co. KG (Mfg Site) has 8 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.