Orthofix U.S. LLC: 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, St

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: 14201 Lot/code info: Lot Code: All Lot Codes/ UDI: 38-2006SP 18257200151769 38-2007SP 18257200151776 38-2008SP 18257200151783 38-2009SP 18257200151790 38-2010SP 18257200151806 38-2011SP 18257200151813 38-2012SP 18257200151820 38-2013SP 18257200151837 38-2014SP 18257200151844 38-2106SP 18257200151875 38-2107SP 18257200151882 38-2108SP 18257200151899 38-2109SP 18257200151905 38-2110SP 18257200151912 38-2111SP 18257200151929 38-2112SP 18257200151936 38-2113SP 18257200151943 38-2114SP 18257200151950 38-2206SP 18257200151981 38-2207SP 18257200151998 38-2208SP 18257200152001 38-2209SP 18257200152018 38-2210SP 18257200152025 38-2211SP 18257200152032 38-2212SP 18257200152049 38-2213SP 18257200152056 38-2214SP 18257200152063 38-2309SP 18257200152094 38-2310SP 18257200152100 38-2311SP 18257200152117 38-2312SP 18257200152124 38-2313SP 18257200152131 38-2314SP 18257200152148 38-2508SP 18257200152360 38-2509SP 18257200152377 38-2510SP 18257200152384 38-2511SP 18257200152391 38-2512SP 18257200152407 38-2513SP 18257200152414 38-2514SP 18257200152421 38-3206SP 18257200152179 38-3207SP 18257200152186 38-3208SP 18257200152193 38-3209SP 18257200152209 38-3210SP 18257200152216 38-3211SP 18257200152223 38-3212SP 18257200152230 38-3213SP 18257200152247 38-3214SP 18257200152254 38-3409SP 18257200152285 38-3410SP 18257200152292 38-3411SP 18257200152308 38-3412SP 18257200152315 38-3413SP 18257200152322 38-3414SP 18257200152339 38-3506SP 18257200152759 38-3507SP 18257200152766 38-3508SP 18257200152773 38-3509SP 1825720015

UPC codes

18257200151769, 18257200151776, 18257200151783, 18257200151790, 18257200151806, 18257200151813, 18257200151820, 18257200151837, 18257200151844, 18257200151875, 18257200151882, 18257200151899, 18257200151905, 18257200151912, 18257200151929, 18257200151936, 18257200151943, 18257200151950, 18257200151981, 18257200151998, 18257200152001, 18257200152018, 18257200152025, 18257200152032, 18257200152049, 18257200152056, 18257200152063, 18257200152094, 18257200152100, 18257200152117, 18257200152124, 18257200152131, 18257200152148, 18257200152360, 18257200152377, 18257200152384, 18257200152391, 18257200152407, 18257200152414, 18257200152421

Source

Official record: FDA (Device enforcement) ↗

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