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U.S. Department of Health and Human Services

Class 2 Device Recall NHance System 150mm

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 Class 2 Recall
NHance System 150mm
see related information
Date Posted September 01, 2010
Recall Status1 Open
Recall Number Z-2345-2010
Recall Event ID 56323
Premarket Notification
510(K) Numbers
K061774  K072685 
Product Classification Posterior Metal/Polymer Spinal System, Fusion - Product Code NQP
Product N-Hance 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 NH60150-1. Lot number: P07M01
Recalling Firm/
Manufacturer
Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester, Pennsylvania 19380-3417
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Lynne Lewis
610-719-5156
Manufacturer Reason
for Recall
package integrity compromised
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 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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