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InterSpace Knee

TECRES SPA · Model SPK0022 · UDI-DI 28031497000583

JWH MBB Prescription

510(k) clearances

157,469

Adverse events (262 deaths)

983

Recalls

315

Facilities

Description

Temporary knee spacer with gentamicin. InterSpace Knee is composed of fully formed gentamicin/polymethylmethacrylate (PMMA) radiopaque bone cement. The device is sterile and single-use. InterSpace Knee is indicated for temporary use (maximum of 180 days) as a total knee replacement (TKR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. InterSpace Knee is applied on the femoral condyles and on the tibial plate following removal of the existing implantand radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). InterSpace Knee 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.).

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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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.