Recall Z-1541-2023 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Linkbio Corp.
LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
| Date | May 4, 2023 (initiated Mar 21, 2023) |
| Status | Open, Classified |
| 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 |
| Root cause | Labeling design |
| Action | LinkBio issued Urgent Medical Device Correction letter on March 21, 2023 to US Distributors. Letter states reason for recall, health risk and action to take: Please take note of the amendment / reinforcement of the Surgical Technique and participate in future offering of product training on the updated technique. Two warnings have been added. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to follow the updated surgical technique. Attendance in future product training on the LINK SL |
| Quantity | 7 units |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152431 | LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating Waldemar Link GmbH & Co. KG, May 9, 2016 |
| K212742 | GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating Waldemar Link GmbH & Co. KG, Sep 16, 2021 |