Equinoxe Humeral Stem recall
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Why was Equinoxe Humeral Stem recalled?
Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Equinoxe Humeral Stem, Primary, Press Fit, 11mm
- Recalling firm
- Exactech, Inc.
- Quantity
- 14 devices
- Distribution
- Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
- Recall date
- January 27, 2021
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)