Date Initiated by Firm |
January 19, 2021 |
Create Date |
March 02, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1159-2021 |
Recall Event ID |
87258 |
Product Classification |
Arthroscope - Product Code HRX
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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.
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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 |
Recalling Firm/ Manufacturer |
ReNovo, Inc. 340 Sw Columbia St Bend OR 97702-1035
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For Additional Information Contact |
Mr. Mark Wells 541-422-8880
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Manufacturer Reason for Recall |
Non-sterile product was shipped to customers labelled as sterile.
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FDA Determined Cause 2 |
Under Investigation by 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.***" |
Quantity in Commerce |
81 units |
Distribution |
US Nationwide distribution in the states of CA, NJ and OR. |
Total Product Life Cycle |
TPLC Device Report
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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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