Recall Z-1834-2017 ยท GFJ Mallet, Surgical, General & Plastic Surgery
Signal Medical Corporation
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
| Date | Apr 17, 2017 (initiated Feb 20, 2017) |
| Status | Terminated |
| Reason | Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet. |
| Root cause | Labeling design |
| Action | On 2/20/2016, URGENT: MEDICAL DEVICE RECALL notifications dated February 10, 2017 were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers are to retain the notice and replace the old Instructions For Use with the updated version. Also, they are to acknowledge receipt of the instructions by signing the notice and emailing to SignalMedical2017@gmail.com or faxing to 810-364-7072. The firm has attached |
| Quantity | 1,640 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.