Z-0168-2020Class II

Ergo 3.2mm K-wire -

Name: Z-0168-2020 Ergo 3.2mm K-wire -
Creator: Exactech, Inc.
Published: 2019-09-10
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2019-09-10 / Terminated

FDA source

Exactech, Inc. began a recall of 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... on 2019-09-10. FDA classified it as Class II and gives the reason as "Potential for the wire to fracture at the threads and remain in the glenoid". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0168-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-10
Posted: 2019-10-21
Terminated: 2023-05-01
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.
Product code: LRN Wire, Surgical
Reason for recall: Potential for the wire to fracture at the threads and remain in the glenoid.
FDA 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 [email protected].
Quantity in commerce: 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.
Product codes and lots: Catalog Number: 321-52-06, All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0168-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0168-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-30	2019-10-21

Product code LRN

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)