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U.S. Department of Health and Human Services

Class 2 Device Recall NFix II System 150mm

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  Class 2 Device Recall NFix II System 150mm see related information
Date Initiated by Firm February 09, 2009
Date Posted September 01, 2010
Recall Status1 Terminated 3 on September 15, 2010
Recall Number Z-2346-2010
Recall Event ID 56323
510(K)Number K061774  K072685  
Product Classification posterior metal/polymer spinal system, fusion - Product Code NQP
Product NFix II System 150mm
The Synthes N-Hance and NFix II rods are intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the spine.
Code Information Catalog number NX60150-1. Lot numbers P06J01, P06J02, P06M01, P06M02, P07D02, P07H01, P07J01, and P07G01
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information Contact Lynne Lewis
610-719-5156
Manufacturer Reason
for Recall		 package integrity compromised
FDA Determined
Cause 2		 Equipment maintenance
Action The firm, SYNTHES, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated February 9, 2009 and an updated letter dated February 12, 2009, with updated expiration information to customers. The letters described the product, problem and action to be taken by customer. The customers were instructed to call Synthes at 1-800-479-6329 if they have any of the identified devices to obtain a Return Authorization Number; complete the enclosed Verification Section attachment and return this letter with the recalled product to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If they do not have the identified product ,complete the Verification Section attachment and return the document to Synthes by Fax 610-719-5120 or scan/email: lewis.lynne@synthes.com. If you have any questions, please call 800-620-7025 x 5454 or 610-719-5454 or contact your Synthes Spine Sales Consultant.
Distribution Worldwide distribution: USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TN , TX, UT, VA, WA, WI, and WV and countries including Denmark, Germany, Korea and Switzerland.
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.
510(K) Database 510(K)s with Product Code = NQP and Original Applicant = N SPINE, INC.
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