FDA Device recall Z-2123-2012
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bon…
- FDA Device
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bon… by Integra Lifesciences, citing incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2123-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-02-09 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences |
| Distribution | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IN, KS, KY, LA, MA, MD, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI |
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.
Identifiers
| code_info | Model #181041S, Batch #s EKU8, EN2D, EN2B, EMOK & EN2B; Model #181051S, Batch #s EJQY, FOSU, ECEB & E179; Model #1810…Model #181041S, Batch #s EKU8, EN2D, EN2B, EMOK & EN2B; Model #181051S, Batch #s EJQY, FOSU, ECEB & E179; Model #181041, Batch #s EB1E, EBKY, ECE9, EHA7, E647, E8NP, E8P7, E8ML, E8N5, E8PV, E8N5 & E5GV; Model #181042, Batch #s E648, EB1F, E8MM, E8NQ, E8PW, E5GW, E8N6, E8P8, E5GY, E8PW & EBKZ; Model #181052, Batch #s E5GY, E64A, E8PY, E5GW, E8PA, E8NS, E8N8, E8MP & EB1H; Model #181051, Batch #s E649, E5GX, E8MN, E8N7, E8P9, E8NR, E8PX, ECEB, EJ79, EB1G, EBLO & ECEB; Model #181052S, Batch #s E8PY, EB1H, EB14 & E8MP; Model #181042S, Batch #s E8MM, EB1F & EBKZ. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2123-2012%22
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