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U.S. Department of Health and Human Services

Class 2 Device Recall Integra 2.7 mm Drilling Guide

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  Class 2 Device Recall Integra 2.7 mm Drilling Guide see related information
Date Initiated by Firm June 14, 2012
Date Posted September 14, 2012
Recall Status1 Terminated 3 on February 20, 2013
Recall Number Z-2381-2012
Recall Event ID 62728
Product Classification Guide, surgical, instrument - Product Code FZX
Product The 2.7mm Drilling Guide is a reusable instrument used in conjunction with a drill to prepare oriented holes in bone for insertion of a Standard Surfix¿ Locking Screw with plates for the Tiblaxis, Uni-CP, Advansys MLP and Advansys DLP compression plate systems.
The Drilling Guides are initially supplied to users in kits containing the devices that comprise the Tibiaxis, Uni-CP, Advansys MLP and Advansys DLP systems. Should the Drilling Guides need to be replaced, they can be replenished by the customer placing an order. The replacement is shipped to the customer in sealed plastic bags.

Uni-CP" Compression Plate The Uni-CP" Compression Plate is indicated for fixation of bone fractures or for bone reconstruction: - Arthrodesis in foot and ankle surgery - Fracture management in the foot and ankle - Mono or bi-cortical osteotomies in the foot and ankle TIBIAXYS" Plates The Newdeal¿ TIBIAXYS" Plates are indicated For fixation of bone fractures or for bone reconstruction. Examples include Osteotomies and fractures of ankle joint, distal tibia and fibula. The Newdeal¿ TIBIAXYS" Plates must be fixed with the Newdeal Surfix¿ 3.5mm diameter fixation screws and lock-screws. ADVANSYS¿ Mid-Foot Plating System: Dorsal Lisfranc Plate (DLP) and Medical Lisfranc Plate (MLP) The Dorsal Lisfranc Plates are intended for fractures, fusions, osteotomies and replantations of small bones at the tarsometatarsal joints The Medial Lisfranc 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
Code Information The Lot No's for the affected 2.7mm Drilling Guides are: E1DT, E4EX, E57T, E5YA, E64W, E6GN, E6RB, E6WP, E7UL, E86B, E8UC, E9PX, E9Q5, E9QD, EBNY, EEYJ, EF11, EFCM, EGT6, EH6X, EHL2, EJB3, EJZE, EKJ4, EKN4, EKZV, EKZW, EL3G, EL3X, ELH8, EMCQ, EMCX, EN19, ENR9, ENRA, ENS0, EPTL, and EPTQ
Recalling Firm/
Manufacturer		 Integra Life Sci.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Sean Luland
609-936-6832
Manufacturer Reason
for Recall		 Integra' s quality system noted an adverse trend in complaints for breakage of the drilling guides during use. None of the complaints resulted in patient injuries but in some cases resulted in an increase in the time to complete the surgical procedure. A physician was consulted to assess patient risk and concluded that any potential for risk would be transient, self-limiting or minor, or result
FDA Determined
Cause 2		 Device Design
Action Integra sent a "SUBJECT: MEDICAL DEVICE RECALL" letter dated June 14, 2012 to all affected customers. The letter identified the product, problem, and action to be taken by the customers. Customers were asked to complete a Recall Acknowledgement and Return Form whether or not they were affected by the recall, and return all their affected inventory to Integra LifeSciences. Customers were asked to contact their regional managers or the firm at 609-936-6832 for questions regarding the recall.
Quantity in Commerce 2,389 units, Catalogue No. 219635ND; 2.7mm Drilling Guides
Distribution Worldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI and the countries of Austria, Czech republic, Denmark, France, Germany, Ireland, Israel, Italy, Kingdom of Saudi Arabia, Lebanon, Norway, Portugal, Switzerland, South Africa, Spain, Sweden, and United Kingdom.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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