Reported May 10, 2023 · Ongoing
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
Linkbio Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Linkbio Corp. · 101 Round Hill Dr Ste 7 · Rockaway, NJ · 07866-1214
Is this the product you have?
- LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP
- SMALL Item Number15-2220/40
- Lot codes and dates
- UDI-DI04026575429073 All lot numbers within expiration date
- Amount recalled
- 5 units
This recall covers 48 products
The agency filed one notice per product. You are reading one of them; the other 47 are below.
35 more are in the archive.
Where it was sold
Why it was recalled
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
This product could cause temporary or reversible health problems — stop using it.
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