ReNovo, Inc. Recall 87258
Description: 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 Retrievers/ Passers C6387 See updated product list attached for details.
ReNovo, Inc. Recall 87258 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1159-2021 |
| Event ID | 87258 |
| Event Description | 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 Retrievers/ Passers C6387 See updated product list attached for details. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of CA, NJ and OR. |
| Quantity | 81 units |
| Recall Reason | Non-sterile product was shipped to customers labelled as sterile. |
| Device Classification | 20210310 |
| Device Code Info | Lot Number L-008926-16037 Lot numbers L-008918-16048, and L-008918-16045 Lot numbers L-008936-16275, and L-008933-16078 |
| Center Classification Date | 20210302 |
| Recall Initiation Date | 20210119 |
| Recalling Firm | ReNovo, Inc. |
| Initial Notification | |
| Similar To |