FDA Medical Device Recalls (openFDA)
Ad-Tech Medical Instrument Corporation: AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
- Recall number
- Z-2544-2019
- Recalling firm
- Ad-Tech Medical Instrument Corporation
- Product
- AD-TECH Drill Sleeve Guides, used with Ad-Tech Placement Kits: (a) REF DSG-90-2.3N (b) REF DSG-6.3-090-2.4N
- Status
- Terminated
- Initiated
- 2019-08-27
- Posted
- not on file
- Terminated
- 2023-04-05
- Reason
- The inner diameter of the drill sleeve guide raw material was found to be under tolerance, potentially resulting in the drill bit seizing in the guide during surgery.
- Root cause
- Under Investigation by firm
- Action
- The firm initiated the recall by letter on 08/27/2019. The firm requested the units be returned.
- Quantity
- 315 units
- Distribution
- NY, PA, WI, AZ, IL, CA, NH, GA, MA, MN, UT, MI, WA, FL, TX, OH, OR, PA, MD, and India, Korea, Taiwan, Canada, Hong Kong, Denmark, Russia, Singapore, Japan, Brazil. UK, Spain, Czech Republic, France
- Lot, serial or model codes
- All serial numbers distributed between January 2014 and May 2019
- 510(k) numbers
- ["K170442"]
- PMA numbers
- not on file
- Product code
- HBG
- Firm FEI
- 2183456
- Firm city
- Oak Creek
- Firm state
- WI
- 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