FDA Device recall Z-2544-2019
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
- FDA Device
- Class II
- terminated
- Published 2019-09-25
On 2019-09-25 the FDA classified a Class II recall of 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 by Ad Tech Medical Instrument, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2544-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-27 |
| Published | 2019-09-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ad Tech Medical Instrument |
| Distribution | AZ, CA, FL, GA, IL, MA, MD, MI, MN, NH, NY, OH, OR, PA, TX, UT, WA, WI |
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
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.
Identifiers
| code_info | All serial numbers distributed between January 2014 and May 2019 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2544-2019%22
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