FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
- Recall number
- Z-0537-2026
- Recalling firm
- Exactech, Inc.
- Product
- Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
- Status
- Open, Classified
- Initiated
- 2025-09-05
- Posted
- 2025-11-17
- Terminated
- not on file
- Reason
- Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- Root cause
- Release of Material/Component prior to receiving test results
- Action
- On 09/05/2025, the firm emailed an "URGENT MEDICAL DEVICE RECALL NOTICE" to customers informing that, during routine inventory review, it was discovered that the a number of parts/products, which were pending design verification testing were incorrectly placed in active internal inventory rather than designated quarantine locations. Several part/products were distributed to customers. Customers are instructed to: "Carefully review this notification to ensure that they fully understand the issue and all actions required. "Immediately identify, quarantine, and return any of the subject devices in their inventory and/or customer s inventory. "Stop and cease use of any affected devices. "Notify all their accounts that may have received these products and extend this recall notice, including the Description of Issue and Potential Clinical Impact, to them. "Complete and Return the attached Recall Inventory Response Form to Exactech via email at recalls@exac.com. For questions or assistance - contact Recall Support Team at recalls@exac.com
- Quantity
- 1
- Distribution
- U.S.: SC O.U.S.: N/A
- Lot, serial or model codes
- Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001
- 510(k) numbers
- ["K042021"]
- 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