FDA
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.
Non-sterile product was shipped to customers labelled as sterile.
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.***"