Recall Z-2244-2018 ยท HXD Clamp
Stryker GmbH
Farabeuf Clamp for 3.5mm Screws PRO, Catalog # 705463
| Date | May 4, 2018 |
| Status | Terminated |
| Reason | Laser etching which indicates whether the device is in compression or distraction mode appears to be on the wrong side of the lever arm |
| Root cause | Other |
| Action | On May 8, 2018, URGENT PRODUCT RECALL and BUSINESS REPLY notices were issued to U.S.A customers via UPS. Customers are encouraged to take the following actions: 1. Inform individuals within your organization who need to be aware of this device recall. 2. Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. Response is required by submitted the completed response form via email to: StrykerOrtho6487@stericycle.com, even though you may not have any physical inventory on site anymore. 3. Quarantine and di |
| Quantity | 18 parts (10 parts quarantined) |
| Distribution | AR, CA, ID, IL, MD, MI, NJ, NY, OK, SD & TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.