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.

This recall is currently active, issued January 19, 2021. It was issued by Renovo, Inc..

Company

Renovo, Inc.

Recall Initiated

January 19, 2021

Recall Number

Z-1159-2021

Quantity

81 units

Firm Location

Bend, OR

Official Source

View on FDA website ↗

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.***"