Recall Z-2123-2012— Integra LifeSciences Corp.

Name: FDA recall Z-2123-2012
Creator: U.S. Food and Drug Administration
Published: 2012-02-09

Class II · Terminated

Class II FDA medical device recall by Integra LifeSciences Corp., initiated 2012-02-09, terminated 2013-02-19. It names one FDA 510(k) clearance: K070241. 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.. Reason: Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery..

Recalling firm: Integra LifeSciences Corp.
Classification: Class II
Status: Terminated
Initiated: 2012-02-09
Terminated: 2013-02-19
Firm location: Plainsboro, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K070241 — MODIFICATION TO LAPIDUS PLATENew Deal, S.A.·cleared 2007-02-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.

Data sourced from openFDA. This site is unofficial and independent of the FDA.