[Recalled] LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04 — Additional Label Warnings: Amendment / reinforcement of the Surgical Technique… | FDA 2023-03-21
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | LINK SLED Knee System ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2030/04 |
|---|---|
| Brand / manufacturer | Linkbio Corp. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1529-2023 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 21 March 2023 |
| EAN / barcode | 04026575044085 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Linkbio Corp.
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.