Recall Z-3211-2017 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Deerfield Imaging
IMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
| Date | Aug 14, 2017 |
| Status | Terminated |
| Reason | incorrect thread on thumbscrews |
| Root cause | Process control |
| Action | The firm notified the consignees by email on 08/14/2017. The letter stated that the screws would be replaced. |
| Quantity | 6 screws |
| Distribution | IL, OR, PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103493 | HEAD FIATION DEVICE (HFD 100) Imris, Inc., Mar 11, 2011 |