Recall Z-1159-2021— ReNovo, Inc.

Name: FDA recall Z-1159-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-19

Class II · Ongoing

Class II FDA medical device recall by ReNovo, Inc., initiated 2021-01-19. FDA's recall record names no specific 510(k) clearance for this event. 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 Retrievers/ Passers C6387 See updated product list attached for details.. Reason: Non-sterile product was shipped to customers labelled as sterile..

Recalling firm: ReNovo, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-01-19
Firm location: Bend, OR, United States

Product 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.

Reason for recall

Non-sterile product was shipped to customers labelled as sterile.

Data sourced from openFDA. This site is unofficial and independent of the FDA.