Drug recall
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of…
FDA recall event 84748 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 84748 |
|---|---|
| Recall numbers | Z-1273-2020 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture… |
| Initiation date | Dec 30, 2019 |
| Report date | Feb 26, 2020 |
| Termination date | May 11, 2021 |
| City | Mansfield |
| State | MA |
| Country | United States |
| FEI number | 1219602 |
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: