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Open, Classified

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.

FDA Recall Z-1159-2021 · Posted None

Recalling FirmReNovo, Inc.
Recall StatusOpen, Classified
Product CodeHRX
Date Initiated2021-01-19
Product Quantity81 units

Reason for Recall

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

Firm Action

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.***"

Root Cause

Under Investigation by firm

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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