Linkbio Corp. Recall 92088
Description: LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11
Linkbio Corp. Recall 92088 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1521-2023 |
| Event ID | 92088 |
| Event Description | LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Item Number: 15-2028/11 |
| Product Type | Devices |
| 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 |
| Quantity | 15 units |
| Recall Reason | 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 |
| Device Classification | 20230510 |
| Device Code Info | UDI-DI: 04026575044030 All lot numbers within the labeled expiration date |
| Center Classification Date | 20230504 |
| Recall Initiation Date | 20230321 |
| Recalling Firm | Linkbio Corp. |
| Initial Notification | |
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