FDA Medical Device Recalls (openFDA)
Signal Medical Corporation: Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
- Recall number
- Z-1834-2017
- Recalling firm
- Signal Medical Corporation
- Product
- Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090
- Status
- Terminated
- Initiated
- 2017-02-20
- Posted
- 2017-04-17
- Terminated
- 2017-08-25
- 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 the revised labeling to the letter.
- Quantity
- 1,640
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All units in distribution
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFJ
- Firm FEI
- 3002477077
- Firm city
- Marysville
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28