6 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0¿, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0¿, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0¿, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0¿, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0¿, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8¿, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0¿, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer,
FDA Enforcement
Class III
·Ongoing·Orthofix U.S. LLC·December 17, 2025
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0¿, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0¿, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8¿, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8¿, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0¿, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8¿, 11W x 31L x 12H;
FDA Enforcement
Class III
·Ongoing·Orthofix U.S. LLC·December 17, 2025
DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgically created osseous defects or osseous defects created from traumatic injury. Model Number: 038100
FDA Enforcement
Class II
·Ongoing·Musculoskeletal Transplant Foundation, Inc.·November 29, 2023
KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·November 6, 2024
KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·April 26, 2023
KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver
FDA Enforcement
Class II
·Ongoing·Pro-Dex Inc·July 12, 2023