Recall Z-2359-2015 ยท HTO Reamer
Synthes (USA) Products LLC
8.5mm Reamer Head for Flexible Intramedullary Nailing System; An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis
| Date | Aug 10, 2015 (initiated Jul 1, 2015) |
| Status | Terminated |
| Reason | The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported. |
| Root cause | Other |
| Action | An urgent notice of medical device recall, dated July 1, 2015, was sent to end users and sales consultants to alert them about the device defect and potential risk to patients. Recipients were asked to complete the verification form and return it along with any affected devices their posession. |
| Quantity | 4329 |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.