Synthes USA (HQ), Inc. 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Synthes USA (HQ), Inc.
Lot Codes / Batch Numbers
Catalog number NX60150-1. Lot numbers P06J01, P06J02, P06M01, P06M02, P07D02, P07H01, P07J01, and P07G01
Products Sold
Catalog number NX60150-1. Lot numbers P06J01, P06J02, P06M01, P06M02, P07D02, P07H01, P07J01, and P07G01
Synthes USA (HQ), Inc. is recalling NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobilization and due to package integrity compromised. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
package integrity compromised
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, FL, GA, IL, IN, KS, LA, MD, MA, MI, MN, MO, NV, NJ, NM, NY, NC, ND, OH, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI
Page updated: Jan 10, 2026