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COPAL® knee moulds

Heraeus Medical GmbH · Model M · UDI-DI 04260102139268

JWH Prescription

510(k) clearances

158,735

Adverse events (262 deaths)

984

Recalls

318

Facilities

Description

COPAL® knee moulds are sterile single-use moulds used for the preparation of spacers that are intended as temporary knee replacements as part of two-stage septic joint prosthesis revision. COPAL® knee moulds comprise a tibial component and a femoral component, which together form a bearing and move against one another. They can be used in both the right and the left knee joint. The spacer function provides that after removal of the prosthesis the existing joint space is retained and contraction of the musculature and the surrounding tissues is prevented. COPAL® knee moulds are intended for single use and must not be re-used or resterilised.

Recalls

Date	Firm	Reason
2026-07-30	Howmedica 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
2026-05-20	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

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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.