Exactech, Inc. Recall 86760
Description: Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Exactech, Inc. Recall 86760 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0884-2021 |
| Event ID | 86760 |
| Event Description | Equinoxe Humeral Stem, Primary, Press Fit, 11mm |
| Product Type | Devices |
| Distribution | Distributed within the US to KS, OH, CA. International distribution to Australia and Germany. |
| Quantity | 14 devices |
| Recall Reason | Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. |
| Device Classification | 20210127 |
| Device Code Info | Catalog Number: 300-01-11; Packaging Lot: 49088921; UDI: 10885862079312; Serial Numbers: 6477393, 6477394, 6477395, 6477397, 6477398, 6477399, 6477400, 6477401, 6477402, 6477403, 6477404, 6477405, 6477406, and 6477407. |
| Center Classification Date | 20210121 |
| Recall Initiation Date | 20201109 |
| Recalling Firm | Exactech, Inc. |
| Initial Notification | |
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