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.
Reported: March 10, 2021 Initiated: January 19, 2021 #Z-1159-2021
Product Description
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.
Reason for Recall
Non-sterile product was shipped to customers labelled as sterile.
Details
- Recalling Firm
- ReNovo, Inc.
- Units Affected
- 81 units
- Distribution
- US Nationwide distribution in the states of CA, NJ and OR.
- Location
- Bend, OR
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by ReNovo, Inc.. Units affected: 81 units.
Why was this product recalled? ▼
Non-sterile product was shipped to customers labelled as sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 10, 2021. Severity: Moderate. Recall number: Z-1159-2021.
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