Z-2123-2012Class II

Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The...

Name: Z-2123-2012 Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The...
Creator: Integra LifeSciences Corp.
Published: 2012-02-09
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2012-02-09 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as... on 2012-02-09. FDA classified it as Class II and gives the reason as "Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2123-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-09
Posted: 2012-08-01
Terminated: 2013-02-19
Recalling firm: Integra LifeSciences Corporation
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.
Product code: HRS Plate, Fixation, Bone
Reason for recall: Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: INTEGRA sent an Urgent Medical Device Correction Notice dated February 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to identify members of surgical team that ues the affected product and make them aware of the Medical Device Correction Notice. Customers were asked to sign and return the enclosed Medical Device Correction Notice Acknowledgement and Return Form and to maintain a copy of the notification and signed copy of the acknowledgment form for their records. For any questions regarding this recall call 609-936-6832..
Quantity in commerce: 2,437 units
Distribution: 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.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2123-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2123-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01

Product code HRS

K070241Class IIModification to Lapidus PlateNew Deal, S.A. / cleared 2007-02-08

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)