Recall Z-2092-2015 ยท HTO Reamer
Synthes, Inc.
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
| Date | Jul 16, 2015 (initiated May 28, 2015) |
| Status | Terminated |
| Reason | It was reported that the RIA Drive Shaft, Tube Assembly, and Reamer Head have the potential to break when incorrectly assembled or used improperly. Precautionary statements are being added to the Reamer / Irrigator / Aspirator (RIA) Surgical Technique Guide. |
| Root cause | Labeling False and Misleading |
| Action | DePuy Synthes sent an Urgent Medical Device Safety Notification dated May 28, 2015, to direct accounts and sales consultants to advise them of the patient risk associated with misassembly or misuse of the device. Customers and sales force were instructed to remove the Surgical Technique Guide J4352 (all versions) dated 11/2011 or earlier and replace it with the updated Technique Guide (DSUS/TRM/0515/0620, Date 06/2015),and to return the completed verification response form. If you have any further questions, please call (610) 719-5450. Thank you for your attention to this matter. |
| Quantity | 132564 |
| Distribution | Nationwide Distribution and Internationally to Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111437 | SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) Synthes (USA) Products, LLC, Aug 10, 2011 |