Recall Z-1159-2021 ยท HRX Arthroscope
ReNovo, Inc.
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.
| Date | Jan 19, 2021 |
| Status | Open, Classified |
| Reason | Non-sterile product was shipped to customers labelled as sterile. |
| Root cause | Under Investigation by firm |
| Action | On 01/19/2021, an URGENT: Medical Device Recall letter was emailed as well as phone call was made to the three affected customers. The letter states in part: "***Do not use any affected product. All products should be immediately quarantined to prevent unintended use. Please confirm receipt of this notification via phone or email, and Provision will provide a Returned Materials Authorization Number along with pre-paid shipping label. Please ship the affected product back to Provision at your earliest convenience. Please actively monitor patient complaints for symptoms of infection and treat a |
| Quantity | 81 units |
| Distribution | US Nationwide distribution in the states of CA, NJ and OR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.