Smith & Nephew, Inc. Recall 87035
Description: 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.
Smith & Nephew, Inc. Recall 87035 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0933-2021 |
| Event ID | 87035 |
| Event Description | 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. |
| Product Type | 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. |
| Quantity | 5190 devices |
| Recall Reason | Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing. |
| Device Classification | 20210210 |
| Device Code Info | Product Number: 71271440; Batch Number: 18LC07540 |
| Center Classification Date | 20210129 |
| Recall Initiation Date | 20201218 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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