FDA-Device2021-03-10Class II
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.
Hazard
Non-sterile product was shipped to customers labelled as sterile.
Sold states
US Nationwide distribution in the states of CA, NJ and OR.
Affected count
81 units
Manufactured in
340 Sw Columbia St, Bend, OR, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1159-2021Don't want to check this manually?
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