FDA Medical Device Recalls (openFDA)
Exactech, Inc.: Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
- Recall number
- Z-0168-2020
- Recalling firm
- Exactech, Inc.
- Product
- Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a conventional technique for total shoulder replacement. The wire is single-use, provided sterile, and intended for transient use.
- Status
- Terminated
- Initiated
- 2019-09-10
- Posted
- not on file
- Terminated
- 2023-05-01
- Reason
- Potential for the wire to fracture at the threads and remain in the glenoid.
- Root cause
- Under Investigation by firm
- Action
- Exactech notified customers of the recall on about 09/10/2019, via "URGENT MEDICAL DEVICE RECALL" letter. Customers were informed that Exactech had received reports of the 3.2mm K-Wire fracturing at the threads and remaining in the glenoid. Instructions included to immediately cease distribution of or use of the product, provide the recall information to accounts that may have the affected product in their possession, identify and quarantine any affected products in inventory, and complete and return the attached Recall Acknowledgement Form and Recall Inventory Response form to Exactech via email at recalls@exac.com.
- Quantity
- 158 devices
- Distribution
- US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.
- Lot, serial or model codes
- Catalog Number: 321-52-06, All Serial Numbers
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRN
- 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