Device product
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Z-0884-2021
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 86760
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 14 devices
- Official record key
device-enforcement:Z-0884-2021
Official wording
Reason: Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
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.
Distribution pattern: Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
Derived failure modes
-
Unknown
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.