FDA recall Z-1159-2021

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 for recall

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

Distribution

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

Key facts

Status

Ongoing

Initiation date

2021-01-19

Report date

2021-03-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bend, OR, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1159-2021