Integra¿ Advansys Medial Lisfranc Plate — Class II medical device recall Z-2123-2012
Terminated recall by Integra LifeSciences Corp., reported 2012-08-08, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
| Recall number | Z-2123-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Plainsboro, NJ, United States |
| Recall initiated | 2012-02-09 |
| Classified | 2012-08-01 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2013-02-19 |
| Distributed | 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 |
| Countries outside the US | BE, CH, DE, ES, FR, GB, IT, LB, NL, NO, PT, SA, TR |
| Quantity | 2,437 units |
| Lot numbers | E5GW, E5GX, E5GY, E648, E649, E64A, E8MM, E8MN, E8MP, E8N6, E8N7, E8N8, E8NQ, E8NR, E8NS, E8P8, E8P9, E8PA, E8PW, E8PX, E8PY, EB14, EB1E, EB1F, EB1H, EKU8, EN2B, EN2D |
| Model numbers | 181041, 181041S, 181042, 181042S, 181051, 181051S, 181052, 181052S |
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 for recall
Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2123-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.