Recall Z-2344-2010 ยท NQP Posterior Metal/Polymer Spinal System, Fusion
Synthes USA (HQ), Inc.
TI N-Hance Rod 150mm Sterile 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.
| Date | Sep 1, 2010 (initiated Feb 9, 2009) |
| Status | Terminated |
| Reason | package integrity compromised |
| Root cause | 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 no |
| 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. |
| FDA record | Open on fda.gov |