Z-1159-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- March 10, 2021
- Initiation Date
- January 19, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81 units
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.
Distribution Pattern
US Nationwide distribution in the states of CA, NJ and OR.
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