Recall Z-2199-2016 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
Synthes (USA) Products LLC
Part # 313.250, 1.1mm Drill Bit, Mini QC with 4mm Stop/44.5mm, lot # 4326989, mfg. 9/28/2001 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
| Date | Jul 12, 2016 (initiated May 31, 2016) |
| Status | Terminated |
| Reason | DePuy Synthes is voluntarily initiating this recall due to affected devices that were distributed, etched and or labeled with MR Safety information not meeting the current ASTM standard. |
| Root cause | Labeling False and Misleading |
| Action | DePuy Synthes mailed an URGENT MEDICAL DEVICE FIELD SAFETY NOTIFICATION letter to their customers (Hospital Personnel, including Imaging Department Personnel and DePuy Synthes Colleague) to inform them of the recall and actions to take. The letter identified the affected, problem and actions to be taken. The letter instructed customers not to use the affected Instruments which are labeled or etched MR Safe and MR Conditional during MRI scans. Customers were asked to review the information contained in the Field Safety Notification letter and complete the Verification Section located on page 3 |
| Quantity | 19 units |
| Distribution | US Nationwide Distribution in the states of: AR,CA,CO,CT,DC,ID,IL,KY,LA,MA,MD,MN,MO,MS,MT,NY,PA and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043310 | SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM Synthes (Usa), Jan 5, 2005 |