Orthofix U.S. LLC: 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,

Hazard

Labeling contains claims that are not consistently present.

Details from the source

Reason for recall: Labeling contains claims that are not consistently present. Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WY and the countries of AU, DE, PR, GB, HU, CZ, CA, CL, AE, ZA, BR. Quantity: 34582 Lot/code info: Lot Code: All Lot codes/ UDI: 38-1007SP 18257200091577 38-1008SP 18257200091584 38-1009SP 18257200091591 38-1010SP 18257200111404 38-1011SP 18257200091614 38-1012SP 18257200091621 38-1013SP 18257200091638 38-1014SP 18257200091645 38-1707SP 18257200092185 38-1708SP 18257200092192 38-1709SP 18257200092208 38-1710SP 18257200092215 38-1711SP 18257200092222 38-1712SP 18257200092239 38-1713SP 18257200092246 38-1714SP 18257200092253 38-1807SP 18257200092024 38-1808SP 18257200092031 38-1809SP 18257200092048 38-1810SP 18257200092055 38-1811SP 18257200092062 38-1812SP 18257200092079 38-1813SP 18257200111305 38-1814SP 18257200092093 38-3007SP 18257200091881 38-3008SP 18257200091898 38-3009SP 18257200091904 38-3010SP 18257200091911 38-3011SP 18257200091928 38-3012SP 18257200091935 38-3013SP 18257200091942 38-3014SP 18257200091959 38-4007SP 18257200091720 38-4008SP 18257200091737 38-4009SP 18257200091744 38-4010SP 18257200091751 38-4011SP 18257200111411 38-4012SP 18257200091775 Part Number GTIN 38-4013SP 18257200091782 38-4014SP 18257200091799 38-4207SP 18257200092109 38-4208SP 18257200092116 38-4209SP 18257200092123 38-4210SP 18257200092130 38-4211SP 18257200092147 38-4212SP 18257200092154 38-4213SP 18257200092161 38-4214SP 18257200092178 38-4508SP 18257200092260 38-4509SP 18257200092277 38-4510SP 18257200092284 38-4511SP 18257200092291 38-4512SP 18257200092307 38-4513SP 18257200092314 38-4514SP 18257200092321 38-6007SP 18257200091805 38-6008SP 18257200091812 38-6009SP 18257200091829 38-

UPC codes

18257200091577, 18257200091584, 18257200091591, 18257200111404, 18257200091614, 18257200091621, 18257200091638, 18257200091645, 18257200092185, 18257200092192, 18257200092208, 18257200092215, 18257200092222, 18257200092239, 18257200092246, 18257200092253, 18257200092024, 18257200092031, 18257200092048, 18257200092055, 18257200092062, 18257200092079, 18257200111305, 18257200092093, 18257200091881, 18257200091898, 18257200091904, 18257200091911, 18257200091928, 18257200091935, 18257200091942, 18257200091959, 18257200091720, 18257200091737, 18257200091744, 18257200091751, 18257200111411, 18257200091775, 18257200091782, 18257200091799

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.