FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Equinoxe Humeral Stem, Primary, Press Fit, 11mm
- Recall number
- Z-0884-2021
- Recalling firm
- Exactech, Inc.
- Product
- Equinoxe Humeral Stem, Primary, Press Fit, 11mm
- Status
- Open, Classified
- Initiated
- 2020-11-09
- Posted
- not on file
- Terminated
- not on file
- Reason
- Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
- Root cause
- Employee error
- Action
- Exactech distributed the recall notice titled, "URGENT PRODUCT RECALL NOTICE" to consignees in possession of affected inventory in the US and Australia on November 9, 2020 via email. In order to comply with the notice, consignees have been instructed to: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices in their inventory. " Complete and return the attached Recall Inventory Response Form to Exactech.
- Quantity
- 14 devices
- Distribution
- Distributed within the US to KS, OH, CA. International distribution to Australia and Germany.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K042021"]
- PMA numbers
- not on file
- Product code
- HSD
- Firm FEI
- 1038671
- Firm city
- Gainesville
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28