Drug recall
AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677)…
FDA recall event 80280 · Class II · Ad-Tech Medical Instrument Corporation
Key facts
| Event ID | 80280 |
|---|---|
| Recall numbers | Z-2539-2018 |
| Recalling firm | Ad-Tech Medical Instrument Corporation |
| Product type | Devices |
| Products | AD-TECH Medical Instrument Corporation Drill Sleeve Guides DSG-6-3-090-2.4N utilizing raw material (RM0677) from the following lots from vendor 00-0001062., AD0021502, AD0021628. Product Usage: The… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The 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. |
| Initiation date | May 2, 2018 |
| Report date | Aug 1, 2018 |
| Termination date | Feb 8, 2019 |
| City | Oak Creek |
| State | WI |
| Country | United States |
| FEI number | 2183456 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: