Linkbio Corp. 2023-05-10 Health serious FDA
Health · FDA · Recall #FDA-Z-1523-2023
LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13 Recall
Issued May 10, 2023 · Linkbio Corp.
In May 2023, Linkbio Corp. recalled the LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Item Number: 15-2028/13 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Linkbio Corp. 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
- Linkbio Corp.
- Category
- Health
- Recall date
- May 10, 2023
- Units affected
- Not reported
- Sold at
- NY, NV Foreign: Bulgaria, France, Italy, Norway, Poland, Sweden, Switzerland, Slovakia, Spain, United Kingdom, Germany, Austria, Argentina,
- Recall number
- FDA-Z-1523-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Linkbio Corp. has 7 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.