Interspace Knee ATS 80/12
TECRES SPA · Model SPK0722 · UDI-DI 28031497001900
Description
Temporary Augmented Tibial Stem Spacer with gentamicin. Interspace Knee ATS is composed of fully formed gentamicin/polymethylmethacrylate (PMMA), radio-opaque bone cement. The device is sterile and single-use. InterSpace Knee ATS is indicated for temporary use (maximum 180 days) as an adjunct to total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process, and where a large tibial defect is present. InterSpace Knee ATS is applied on the tibial plate following removal of the existing implant and radical debridement. The device must be combined with the tibial component of InterSpace Knee. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee ATS is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.). Because of the inherent mechanical limitations of the device material (gentamicin/ polymethylmethacrylate), the Interspace Knee ATS is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers, canes) throughout the implantation period.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-20 | United Orthopedic Corp. | Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail. |
| 2026-02-16 | Encore Medical, LP | Due to packaging discrepancy with incorrect product size mixed up. |
| 2026-02-16 | Encore Medical, LP | Due to packaging discrepancy with incorrect product size mixed up. |
| 2026-01-15 | Encore Medical, LP | Knee and Humeral socket implants contain incorrect labeling. |
| 2026-01-05 | Encore Medical, LP | 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discr |
| 2025-07-31 | Waldemar Link GmbH & Co. KG (Mfg Site) | Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. |
| 2025-07-09 | Encore Medical, LP | Knee implants contain incorrect labeling (size and/or side incorrect) |
| 2025-07-09 | Encore Medical, LP | Knee implants contain incorrect labeling (size and/or side incorrect) |
| 2025-06-02 | Encore Medical, LP | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could resu |
| 2025-06-02 | Encore Medical, LP | Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could resu |
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