Device 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.
Z-1159-2021
Product summary
- Firm
- ReNovo, Inc.
- Event
- Event 87258
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 81 units
- Official record key
device-enforcement:Z-1159-2021
Official wording
Reason: Non-sterile product was shipped to customers labelled as sterile.
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
Distribution pattern: US Nationwide distribution in the states of CA, NJ and OR.
Derived failure modes
-
Sterility assurance
Non-sterile product was shipped to customers labelled as sterile