Recall Z-1478-2022 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
Stryker Instruments
Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.
| Date | Jun 24, 2022 |
| Status | Open, Classified |
| Reason | There is a potential for the core diameter to be undersized, which may lead to the router breaking. A break can lead to unintended metal fragments in the surgical site, resulting in the potential for surgical intervention or damage to critical neurological or vascular structures. |
| Root cause | Process change control |
| Action | On June 24, 2022, the firm notified customers via Urgent Medical Device Recall Letters. Customers were instructed to locate and quarantine any affected products found in their inventory. Upon receiving the customer's completed response form, the firm will provide a shipping label to return any recalled product. Upon receipt of the recalled product, Stryker will contact the customer to arrange for replacement product. |
| Quantity | 543 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Arizona, California, Florida, Georgia, Iowa, Michigan, Missouri, New Mexico, North Carolina, Ohio, Texas, Virginia and the countries of Canada, Netherlands, and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143320 | Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments Stryker Corp., Apr 23, 2015 |