Smith & Nephew, Inc. Recall 88975
Description: Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile.
Smith & Nephew, Inc. Recall 88975 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0265-2022 |
| Event ID | 88975 |
| Event Description | Smith and Nephew EVOS Self-Tapping Locking Screw SST: (1)REF 72413575, 3.5MM x 75MM, and (2) REF 72413570, 3.5MM X 70MM. Sterile. |
| Product Type | Devices |
| Distribution | Distribution was made to AL, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, ME, MI, MN, MO, NC, NJ, NY, OH, OR, PA, TN, TX, and WA. There was no direct government distribution. There was no military distribution. Foreign distribution was made to Australia, Canada, China, Dubai/MENA, Germany, Italy, Japan, Netherlands, Singapore, and Thailand. |
| Quantity | 224 units |
| Recall Reason | The labels on the packages of screws were switched. |
| Device Classification | 20211124 |
| Device Code Info | REF 72413575 - batch #21FM24289; REF 72413570 - batch #21GM04743. |
| Center Classification Date | 20211118 |
| Recall Initiation Date | 20211025 |
| Recalling Firm | Smith & Nephew, Inc. |
| Initial Notification | Letter |
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