Recall Z-0587-2021 ยท HTO Reamer
Synthes (USA) Products LLC
DePuy Synthes 18.0MM REAMER HEAD FOR RIA 2 STERILE-Orthopedic manual surgical instrument Part Code: 03.404.032S
| Date | Nov 19, 2020 |
| Status | Terminated |
| Reason | RIA 2 reamer head breakage exceeds the expected occurrence rate resulting in adverse tissue reaction, soft tissue damage, and/or bone damage, when the recommended surgical techniques are not followed |
| Root cause | Use error |
| Action | DePuy Synthes issued voluntary device correction letter on 11/19/202 via 2-day by Fed Ex, stating reason for recall, health risk and action to take: This safety notification is advising physicians of the following supplemental information regarding the surgical approach of standard IM nail reaming as referred to in the surgical technique guide. Open the medullary canal and conduct reaming by following AO reaming techniques for IM nailing and maintain a guide wire entry angle of less than 10 from the axis of the canal. CAUTION: If the guide wire entry angle is greater than 10 from the axis o |
| Quantity | 542 US ; 154 OUS |
| Distribution | Nationwide Foreign:countries: United Arab Emirates, Austria, Australia, Belgium, Switzerland, China, Czech Republic, Germany, Spain, United Kingdom, Ireland, Israel, Italy, Singapore, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K013527 | MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM Synthes (Usa), Dec 21, 2001 |
| K042899 | SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS Synthes (Usa), Mar 16, 2005 |
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) Synthes (USA) Products, LLC, Aug 10, 2011 |
| K993335 | SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM Synthes (Usa), Jun 12, 2000 |