FDAFDA · Food and drugs·Recall number Z-1539-2023
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
Published May 10, 2023 · Recall initiated: March 21, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Linkbio Corp.
- Distributor
- NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina, Australia, China, India, Iraq, Jordan, Colombia, Mexico, Saudi Arabia, Ukraine, Vietnam, and Belarus
- Lot
- UDI-DI: 04026575429073 All lot numbers within expiration date
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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