Recall Z-3273-2011 ยท FMF Syringe, Piston
Synthes USA (HQ), Inc.
Synthes Bone Marrow Aspiration System, Sterile, 11 gauge, 15cm needle (without side holes) Indicated for aspirating bone marrow
| Date | Sep 21, 2011 (initiated Jan 26, 2011) |
| Status | Terminated |
| Reason | Firm became aware that some systems were released to stock without going through the sterilization process. |
| Root cause | Nonconforming Material/Component |
| Action | Synthes (USA) sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. Affected product removed from inventory will be replaced by Synthes. Contact the Synthes Spine Sale Consultant at 1-800-620-7025 ext.6883 for questions concerning this recall. |
| Quantity | 96 parts |
| Distribution | Nationwide Distribution-including the states of AR, CO, FL, GA, ID, LA, MA, MD, MO, MT, NY, NC, OH, SC, SD, TN, TX, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051720 | SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE Synthes (Usa), Jul 25, 2005 |