Recall Z-1952-2011 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
ArthroCare Corporation
ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
| Date | Apr 12, 2011 (initiated Sep 30, 2010) |
| Status | Terminated |
| Reason | During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly. |
| Root cause | Process control |
| Action | On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 170 units |
| Distribution | Product was released for distribution in US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090615 | OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE Arthrocare Corp., Jun 3, 2009 |