Recall Z-1273-2020 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Smith & Nephew, Inc.
TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.
| Date | Dec 30, 2019 |
| Status | Terminated |
| Reason | Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device. |
| Root cause | Package design/selection |
| Action | Smith Nephew "Urgent Medical Device Recall Notice R-2019-22" letter dated December 30, 2019. Customers were advised to: 1.Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities tha |
| Quantity | 82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG |
| Distribution | Worldwide distribution US Nationwide distribution in the states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG. |
| FDA record | Open on fda.gov |