Recall Z-2123-2012 · HRS Plate, Fixation, Bone
Integra LifeSciences Corp.
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.
| Date | Aug 1, 2012 (initiated Feb 9, 2012) |
| Status | Terminated |
| Reason | Incorrect technique applied may cause potential rupture of the tibialis anterior tendon during surgery. |
| 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 regar |
| Quantity | 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; Nether |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070241 | MODIFICATION TO LAPIDUS PLATE New Deal, S.A., Feb 8, 2007 |