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COPAL® exchange G

Heraeus Medical GmbH · Model knee M · UDI-DI 04260102136946

JWH Prescription
1
510(k) clearances
158,131
Adverse events (262 deaths)
984
Recalls
316
Facilities

Description

The COPAL® exchange G Hip and Knee Spacers devices provide patients, undergoing a two-stage revision procedure for an infected total joint, a temporary implant to l) allow for partial weight bearing and 2) provide an approximate natural range of motion. The devices also maintain a patient's soft tissue and joint space, preventing further complications such as muscular contraction. The gentamicin protects the device from bacterial colonization. The COPAL® exchange G Hip and Knee Spacers are placed into the joint to maintain normal joint space and alignment. They provide patient comfort and limited mobility while the infection is being treated. The COPAL® exchange G Hip and Knee Spacers are made with bone cement that are loaded with gentamicin antibiotics. The COPAL® exchange G Hip and Knee Spacers are temporary joint prostheses designed to temporarily replace an infected implant during a total hip or knee arthroplasty and provide the patient with limited mobility and predictable, consistent local antibiotic release.

Recalls

DateFirmReason
2026-07-30Howmedica Osteonics Corp.Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels o
2026-05-20United Orthopedic Corp.Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
2026-02-16Encore Medical, LPDue to packaging discrepancy with incorrect product size mixed up.
2026-02-16Encore Medical, LPDue to packaging discrepancy with incorrect product size mixed up.
2026-01-15Encore Medical, LPKnee and Humeral socket implants contain incorrect labeling.
2026-01-05Encore Medical, LP942-01-40G 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
2025-07-31Waldemar Link GmbH & Co. KG (Mfg Site)Some modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect.
2025-07-09Encore Medical, LPKnee implants contain incorrect labeling (size and/or side incorrect)
2025-07-09Encore Medical, LPKnee implants contain incorrect labeling (size and/or side incorrect)
2025-06-02Encore Medical, LPDue 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.