Linkbio Corp. Recall: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 M
Linkbio Corp. Recall: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 M is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Linkbio Corp.; Product: LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11; Reason for recall: Additiona
| Recalling firm | Linkbio Corp. |
|---|---|
| Product | LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11 |
| Reason for recall | 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 |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | 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 |
| Recall initiated | 20230321 |
| Recall number | Z-1550-2023 |
| Category | device |
| State | NJ |
| Country | United States |
$29/mo
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