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

FDA device recall Z-2123-2012 · posted 2012-08-01 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

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

Action taken

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..

Root cause

Labeling design

Status

Terminated

Product code

HRS

Quantity affected

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 a

Date initiated

2012-02-09

Date posted

2012-08-01

Date terminated

2013-02-19

Location

Plainsboro, NJ

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