Drug recall
MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and…
FDA recall event 85899 · Class II · Synthes, Inc.
Key facts
| Event ID | 85899 |
|---|---|
| Recall numbers | Z-2698-2020 |
| Recalling firm | Synthes, Inc. |
| Product type | Devices |
| Products | MatrixNEURO Screws - Product Usage: The intended use for this device is in fixation of cranial bones and facial skeleton in procedures such as craniotomies, reconstructive procedures, fracture repair… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | One lot of MatrixNEURO 5mm screws was packaged in a body clip etched "4", which indicated a 4mm screw. The outer package labeling correctly identifies a 5mm screw, but the body clop incorrectly… |
| Initiation date | Jun 18, 2020 |
| Report date | Aug 5, 2020 |
| Termination date | Apr 13, 2021 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3005180112 |
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: