Recall Z-0968-2009 ยท NPQ Test, Factor V Leiden Mutations, Genomic Dna Pcr
Synthes Spine
NFlex Stabilization System 150 mm, Catalog number NF60150-1. spinal fusion surgery
| Date | Feb 3, 2009 (initiated Nov 7, 2008) |
| Status | Terminated |
| Reason | the dimensional specifications are incorrect |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued an e-mail on 11/18/08 to their sales force to inform them of the problem and the need to remove the product.The recalling firm issued Medical Device recall letters dated 11/19/08 to their customers to inform them of the problem and the need to return the product. Contact Synthes at 800-620-7025 ext. 7025 or 610-719-5750 for additional information. |
| Quantity | 1508 (total) |
| Distribution | Worldwide: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MO, NC, ND, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: Germany, Denmark, Switzerland, and Korea. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072685 | NGARDE SYSTEM N Spine, Inc., Oct 19, 2007 |