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
- Recall Number
- Z-2346-2010
- Event Number
- 56323
- Firm
- Synthes USA (HQ), Inc.
- FEI Number
- 3005180112
- Product Code
- NQP
- Status
- Terminated
- Root Cause
- Equipment maintenance
- Initiated
- February 9, 2009
- Posted
- September 1, 2010
- Terminated
- September 15, 2010
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
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.
package integrity compromised
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: [email protected]. If you have any questions, please call 800-620-7025 x 5454 or 610-719-5454 or contact your Synthes Spine Sales Consultant.
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.