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U.S. Department of Health and Human Services

Class 2 Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm

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  Class 2 Device Recall Kwire, Smooth Doublepointed 0.8 x 90mm see related information
Date Initiated by Firm May 20, 2016
Create Date June 28, 2016
Recall Status1 Terminated 3 on November 16, 2016
Recall Number Z-2084-2016
Recall Event ID 74224
Product Classification Passer, wire, orthopedic - Product Code HXI
Product K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System
The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
Code Information Lot 237830TE
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact David E. Gronostajski
609-936-6822
Manufacturer Reason
for Recall		 The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Integra sent an Urgent Voluntary Medical Device Recall letter dated May 20, 2016, to all affected consignees regarding the recall via traceable courier service. The letter identified the product, the problem, and the action to be taken by the customer. Customers who have supplied affected product should forward a copy of the Recall Notice to them. Customers should review their inventory for affected product, complete the form as to whether they have any affected product or not, return the form by email or fax as indicated on the form. Customers with questions should contact Customer Service at 1-800-654-2873. For questions regarding this recall call 609-936-6822.
Quantity in Commerce 182 units
Distribution Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
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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