Drug recall
ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft…
FDA recall event 95178 · Class II · Smith & Nephew Inc.
Key facts
| Event ID | 95178 |
|---|---|
| Recall numbers | Z-3096-2024, Z-3097-2024 |
| Recalling firm | Smith & Nephew Inc. |
| Product type | Devices |
| Products | ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 2504-1, ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number: 72205201 |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| Initiation date | Aug 12, 2024 |
| Report date | Sep 18, 2024 |
| City | Andover |
| State | MA |
| Country | United States |
| FEI number | 3003604053 |
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: