Device recall
Z-1159-2021: Various reprocessed products: PROVISION, Reprocessed Smith and Nephew…
FDA device recall · Class II · ReNovo, Inc.
Key facts
| Recall number (Z-number) | Z-1159-2021 |
|---|---|
| Recall event | 87258 |
| Product | Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Reprocessed Depy Mitek Ablation Electrodes, VAPR COOLPULSE 90 deg; PROVISION Reprocessed Smith and Nephew Trocars/ Cannulas (Class I); PROVISION Reprocessed Conmed/ Linvatec Suture… |
| Product code | HRX |
| Recalling firm | ReNovo, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3014023545 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database