Waldemar Link GmbH & Co. KG (Mfg Site) 2022-07-20 Health serious FDA
Health · FDA · Recall #FDA-Z-1380-2022
Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 … Recall
Issued July 20, 2022 · Waldemar Link GmbH & Co. KG (Mfg Site)
In July 2022, Waldemar Link GmbH & Co. KG (Mfg Site) recalled the Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
What you should do
- 1 Stop using Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 … 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
- July 20, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia
- Recall number
- FDA-Z-1380-2022
- 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 870th Health recall we've logged in 2022.