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U.S. Department of Health and Human Services

Class 2 Device Recall NFlex Stabilization System 150mm

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 Class 2 Device Recall NFlex Stabilization System 150mmsee related information
Date Initiated by FirmFebruary 09, 2009
Date PostedSeptember 01, 2010
Recall Status1 Terminated 3 on September 15, 2010
Recall NumberZ-2348-2010
Recall Event ID 56323
510(K)NumberK061774 K072685 
Product Classification posterior metal/polymer spinal system, fusion - Product Code NQP
ProductNFlex Stabilization 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 NF60150-1. Lot numbers: P06H01, P06J01, P06M01, P07H02, P07J02, and P07M03
Recalling Firm/
Manufacturer		 Synthes USA (HQ), Inc.
1302 Wrights Ln E
West Chester PA 19380-3417
For Additional Information ContactLynne Lewis
610-719-5156
Manufacturer Reason
for Recall		package integrity compromised
FDA Determined
Cause 2		Equipment maintenance
ActionThe 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.
DistributionWorldwide 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 CycleTPLC 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) Database510(K)s with Product Code = NQP
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