Recall Z-0933-2021 ยท LOD Bone Cement
Smith & Nephew, Inc.
VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.
| Date | Dec 18, 2020 |
| Status | Terminated |
| Reason | Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing. |
| Root cause | Storage |
| Action | A Recall notification letter titled, "Urgent Medical Device Recall Notice" was sent to consignees on 12/18/2020 via email and FedEx. The letter instructs the consignee to follow the instructions on the attached response form. The response form provides the following instructions: "1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions |
| Quantity | 5190 devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022688 | VERSABOND AB BONE CEMENT Smith & Nephew, Inc., Apr 29, 2004 |