Recall Z-1147-2020 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Stryker Corporation
Stryker, Omega 4.75 mm,. PEEK Knotless Anchor System, Double-Double, REF 3910-500-472, UDI 07613327464832, Sterile R, RX Only CE 0197
| Date | Mar 2, 2020 (initiated Jul 19, 2019) |
| Status | Terminated |
| Reason | Complaints have been received regarding difficulty in removing the driver from the screw. High driver removal forces can lead to the screw pulling out still attached to the driver. This could result in an additional anchor insertion site in the bone being used. |
| Root cause | Nonconforming Material/Component |
| Action | On July 23, 2019, a "Urgent Medical Device Recall Notification" was emailed to sales representatives. In addition to informing consignees on the cause of the recall, the following action was requested: 1. Check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your accounts. Response is required by August 15, 2019. 2.If affected product is found in your inventory, segregate the product and call Stryker customer service at 1-866-596-2022 or email smwest@stryker.com to arrange for product return and issuance of credit or replaceme |
| Quantity | 73 devices |
| Distribution | US: GA, NJ, NY, KY, MD, TX, UT, AZ, IL, ID, CO, OH, FL, AK, CA, NV, AR, ME, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K181083 | Stryker All-PEEK Knotless Anchor System Stryker, Jul 23, 2018 |