Reported Aug 8, 2012 · Terminated
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates…
Integra LifeSciences Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. · 311 Enterprise Dr · Plainsboro, NJ · 08536-3344
Is this the product you have?
- Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates
- are intended for bone fixation such asArthrodesis 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
- Lot codes and dates
8 of 8 products
Products covered by this recall Model / number Product as published 181041SBatch #s EKU8, EN2D, EN2B, EMOK & EN2B 181051SBatch #s EJQY, FOSU, ECEB & E179 181041Batch #s EB1E, EBKY, ECE9, EHA7, E647, E8NP, E8P7, E8ML, E8N5, E8PV, E8N5 & E5GV 181042Batch #s E648, EB1F, E8MM, E8NQ, E8PW, E5GW, E8N6, E8P8, E5GY, E8PW & EBKZ 181052Batch #s E5GY, E64A, E8PY, E5GW, E8PA, E8NS, E8N8, E8MP & EB1H 181051Batch #s E649, E5GX, E8MN, E8N7, E8P9, E8NR, E8PX, ECEB, EJ79, EB1G, EBLO & ECEB 181052SBatch #s E8PY, EB1H, EB14 & E8MP 181042SBatch #s E8MM, EB1F & EBKZ. - Amount recalled
- 2,437 units
Where it was sold
Why it was recalled
Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
This product could cause temporary or reversible health problems — stop using it.
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