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.

Company

Renovo, Inc.

Recall Initiated

January 19, 2021

Recall Number

Z-1159-2021

Quantity

81 units

Firm Location

Bend, OR

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.

Lot / Code Info

Lot Number L-008926-16037 Lot numbers L-008918-16048, and L-008918-16045  Lot numbers L-008936-16275, and L-008933-16078

Root Cause

Under Investigation by firm

Action Taken

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 as deemed necessary.***"