Orthofix U.S. LLC: Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, 5¿ Lordotic 37-6005SP 12mm W X 12mm

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: 40956 Lot/code info: Lot Code: All Lot Codes/ UDI: 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6005SP 18257200150151 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6006SP 18257200150168 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6007SP 18257200150175 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6008SP 18257200150182 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6009SP 18257200150199 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6010SP 18257200150205 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6011SP 18257200150212 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6012SP 18257200150229 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6105SP 18257200149759 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6106SP 18257200149766 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6107SP 18257200149773 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6108SP 18257200149780 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6109SP 18257200149797 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6110SP 18257200149803 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6111SP 18257200149810 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6112SP 18257200149827 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6206SP 18257200150557 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6207SP 18257200150564 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6208SP 18257200150571 37-6209SP 18257200150588 37-6209SP 1825720015

UPC codes

18257200150151, 18257200150168, 18257200150175, 18257200150182, 18257200150199, 18257200150205, 18257200150212, 18257200150229, 18257200149759, 18257200149766, 18257200149773, 18257200149780, 18257200149797, 18257200149803, 18257200149810, 18257200149827, 18257200150557, 18257200150564, 18257200150571, 18257200150588, 18257200150595, 18257200150601, 18257200150618, 18257200150915, 18257200150922, 18257200150939, 18257200150946, 18257200150953, 18257200150960, 18257200150977, 18257200150250, 18257200150267, 18257200150274, 18257200150281, 18257200150298, 18257200150304, 18257200150311, 18257200150328, 18257200149858, 18257200149865

Source

Official record: FDA (Device enforcement) ↗

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