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Integra LifeSciences Corp. recalls Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plat
Recalled August 8, 2012 · FDA recall Z-2123-2012 · Integra LifeSciences
Hazard
Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery. · FDA Class II
Units
2,437 units
Sold at
Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NM, NJ, NY, NV, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA & WI and internationally to Belgium; Danemark; France; Germany; Isra¿l; Italy; Lebanon; Luxemburg; Netherlands; Norway; Portugal; Saudi Arabia; Spain; Switzerland; Turkey & United Kingdom.
Description
Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
Product
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
Manufacturer(s)
Integra LifeSciences Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →