Z-0884-2021 Class II Ongoing
FDA device recall Z-0884-2021 was initiated by Exactech, Inc. on November 9, 2020 and is designated Class II. Reason for recall: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package. The recall status is ongoing. Affected quantity: 14 devices.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2021
- Initiation Date
- November 9, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14 devices
Product Description
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Reason for Recall
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
Distribution Pattern
Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
Code Information
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.