Recall Z-0585-2016 ยท HTO Reamer
Synthes (USA) Products LLC
SYNTHES; 13.5MM Medullary Reamer Head; 352.135 NON STERILE. Part of the Flexible Reamer Set for orthopedic surgical procedures.
| Date | Jan 5, 2016 (initiated Dec 1, 2015) |
| Status | Terminated |
| Reason | The 13.5mm Medullary Reamer head, lot #F-17180, is etched as dimension 13.5mm while the actual dimension is 14mm. |
| Root cause | Process design |
| Action | On Dec 1, 2015, Synthes issued a recall notification letter and requested that all consignees review inventory and contact Synthes for a return authorization number. The verification form is to be completed and sent to Stericycle. |
| Quantity | 65 |
| Distribution | US nationwide distibution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.