Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-1
FDA device recall Z-2092-2015 · posted 2015-07-16 · Terminated
Recall details
- Recalling firm
- Synthes, Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- HTO
- Quantity affected
- 132564
- Distribution
- Nationwide Distribution and Internationally to Canada and Switzerland.
- Date initiated
- 2015-05-28
- Date posted
- 2015-07-16
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES RIA SYSTEM (EXPANDED INDICATIONS) (K111437) | Synthes (USA) Products, LLC | 2011-08-10 |