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U.S. Department of Health and Human Services

Class 2 Device Recall Arthroscopes and accessories

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 Class 2 Device Recall Arthroscopes and accessoriessee related information
Date Initiated by FirmJanuary 19, 2021
Create DateMarch 02, 2021
Recall Status1 Open3, Classified
Recall NumberZ-1159-2021
Recall Event ID 87258
Product Classification Arthroscope - Product Code HRX
ProductVarious 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.
Code Information Lot Number L-008926-16037 Lot numbers L-008918-16048, and L-008918-16045  Lot numbers L-008936-16275, and L-008933-16078 
FEI Number 3014023545
Recalling Firm/
Manufacturer		 ReNovo, Inc.
340 Sw Columbia St
Bend OR 97702-1035
For Additional Information ContactMr. Mark Wells
541-422-8880
Manufacturer Reason
for Recall		Non-sterile product was shipped to customers labelled as sterile.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn 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.***"
Quantity in Commerce81 units
DistributionUS Nationwide distribution in the states of CA, NJ and OR.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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