Recall Z-1834-2017
Signal Medical Corporation · initiated February 20, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
Codes / lots: All units in distribution
Reason for recall
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.
FDA-determined cause: Labeling design
Action taken
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 the revised labeling to the letter.
Details
- Recall number
- Z-1834-2017
- Initiated
- February 20, 2017
- Posted by FDA
- April 17, 2017
- Terminated
- August 25, 2017
- Product code
- GFJ – Mallet, Surgical, General & Plastic Surgery
- Quantity
- 1,640
- Distribution
- Nationwide Distribution.
- Recalling firm
- Signal Medical Corporation, Marysville, MI