FDA Medical Device Recalls (openFDA)
Ace Surgical Supply Co., Inc.: Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
- Recall number
- Z-1464-2018
- Recalling firm
- Ace Surgical Supply Co., Inc.
- Product
- Double Blade Shoe F/Unigraft Knife 1.5 Thick X 9MM SKU 6500009 Used to achieve epithelial graft in the oral cavity.
- Status
- Terminated
- Initiated
- 2018-03-28
- Posted
- not on file
- Terminated
- 2018-09-11
- Reason
- The product inside the package is incorrect. A single blade shoe was mistakenly packaged instead of a double blade.
- Root cause
- Error in labeling
- Action
- ACE is contacting the 5 affected customers via certified mail for US customers and via email for non-US Customers. Follow-up notifications will be sent 12 weeks after initial notification. Firm will rework incorrectly packaged product and will use completed reply forms as effectiveness check. For further questions, please call (508) 588-3100.
- Quantity
- 6
- Distribution
- US Distribution to the states of : MI, CA, OK, and Internationally to China, Canada,
- Lot, serial or model codes
- Lot # M050225
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EMO
- Firm FEI
- 1287163
- Firm city
- Brockton
- Firm state
- MA
- 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