ReNovo product recalled over sterility concerns

Recall date

January 19, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

ReNovo, Inc. recalls Various reprocessed products: PROVISION, Reprocessed Smith and Nephew Arthroscopic Shavers, STERILE EO; PROVISION Repro…

Recall number

Z-1159-2021

FDA classification

Class II

Brand / firm

ReNovo, Inc.

Sold / distributed

US Nationwide distribution in the states of CA, NJ and OR.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.