COPAL® exchange G
Heraeus Medical GmbH · Model hip XL short · UDI-DI 04260102136885
Description
COPAL® exchange G hip spacer is a temporary hip spacer implant as part of two-stage septic endoprosthesis revision based on bone cement. COPAL® exchange G hip spacer contains gentamicin. Gentamicin reduces the risk for bacterial colonization of the device and is released into the fluid surrounding the joint. COPAL® exchange G hip spacer is intended for single-use and is supplied sterile. COPAL® exchange G hip spacer is made of fully formed polymethylmethacrylate (radiopaque PMMA with gentamicin) and contains an inner stainless steel (AISI 316L) reinforcing structure. It contains the X-ray contrast medium calcium carbonate. To improve visibility in the surgical field, it has been colored with chlorophyll-copper-complex (E141).
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 |
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the |
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the |
| 2024-06-19 | Howmedica Osteonics Corp. | Mislabeled: the size on the package label of the UNITRAX Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the |
| 2018-06-21 | DePuy Orthopaedics, Inc. | Two lots of femoral stems were labeled as Size 11. However, they are actually Size 12. Potential adverse effects include poor joint mechanics, improper fit, loosening, and addition |
| 2017-07-12 | DePuy Orthopaedics, Inc. | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH |
| 2017-07-12 | DePuy Orthopaedics, Inc. | Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 (Part No. 3L93709 / Lot No. 5291990), contained the CORAIL HIGH |
| 2015-11-16 | Smith & Nephew, Inc. | The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birmingham Hip Modular Head, with labeling not cleared for marketing in the US. The actua |
| 2009-06-26 | Stryker Howmedica Osteonics Corp. | The raw material used in the production of the Unipolar adaptor sleeve and the Restoration modular products are not affected by the previously mentioned metallurgical non-complianc |
| 2009-01-06 | Stryker Howmedica Osteonics Corp. | Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity. |
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