Recall Z-0253-2018 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
ConMed Corporation
Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.
| Date | Apr 17, 2017 |
| Status | Terminated |
| Reason | Manufactured with the incorrect anchor outer body |
| Root cause | Mixed-up of materials/components |
| Action | On April 17, 2017 CONMED distributed Urgent Device Recall notices and business reply forms to customers via USPS First Class. Customers are instructed to stop use of the devices immediately and to review inventory for any of the affected product. CONMED requests that customers contact all departments within their facilities and any other facilities within your organization that may have received affected products. It is imperative that all end users of these devices receive the notice and respond immediately. Customers who have received affected product are expected to complete the Busines |
| Quantity | 56 units |
| Distribution | CA, IN, KS, MD, NY, OH, PA, TN, TX & WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K091549 | CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM Linvatec Corp., Jun 23, 2009 |