Recall Z-0867-2017 ยท FSM Tray, Surgical, Instrument
Synthes (USA) Products LLC
Synthes VA Implant Rack for the Compact Distal Radius System Tray/Surgical/Instrument
| Date | Dec 21, 2016 (initiated Nov 29, 2016) |
| Status | Terminated |
| Reason | The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack. |
| Root cause | Process control |
| Action | DePuy Synthes mailed an Urgent Notice Medical Device Recall letter to all affected customers informing them of the potential impacts, actions to be taken and instructions for the product return. Customers were instructed to immediately review their inventory to identify and quarantine all affected products, complete the attached Verification Section and send a copy to Depuy Synthes by scan/email: Synthes5748@stericycle.com or fax to 1-888-943-5169. If any of the affected product has been forwarded to another facility, contact the facility to arrange return. Customers with questions were in |
| Quantity | 31 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.