FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
- Recall number
- Z-0307-2021
- Recalling firm
- Exactech, Inc.
- Product
- Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
- Status
- Terminated
- Initiated
- 2020-09-25
- Posted
- not on file
- Terminated
- 2023-05-01
- Reason
- The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
- Root cause
- Process control
- Action
- The recalling firm distributed a recall notice to US consignees with affected inventory on 09/25/2020. The recall notice was translated and provided to OUS consignees on 10/082020. 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 Recall Inventory Response Form to Exactech.
- Quantity
- 25 devices
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of CA, CO, FL, IN, KY, NY, OH, TX, and Puerto Rico. The countries of Australia, Germany, France, Spain, India, Italy, South Korea, Singapore, UK, Luxembourg, and Brazil.
- Lot, serial or model codes
- Catalog: 304-21-07; Serial Ranges: 4968615-4968627; 4952421-4952432
- 510(k) numbers
- ["K092900","K101909"]
- PMA numbers
- not on file
- Product code
- PHX
- 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