CLASS II Device recall · Reported 30 Oct 2019 · FDA Enforcement Report

Ergo K-wire recalled by Exactech

Exactech is recalling Ergo K-wire, distributed nationwide in the US. The recall was initiated on 10 Sep 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 321-52-06, All Serial Numbers

Quantity recalled158 devices

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0168-2020
FDA event ID: 83855
Recalling firm: Exactech, Gainesville, FL
Classification: Class II
Status: Terminated
Recall initiated: 10 Sep 2019
FDA classified: 21 Oct 2019
Reported: 30 Oct 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Sep 2019	Recall initiated by company
21 Oct 2019	Classified by FDA	+41 days
30 Oct 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential for the wire to fracture at the threads and remain in the glenoid.

Product as listed by the FDA

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.

Where it was distributed

US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.

Nationwide Arkansas Arizona California Colorado Florida Illinois Indiana Kansas Louisiana Minnesota New York Ohio South Carolina Tennessee Texas Virginia Washington

Questions about this recall

Why was it recalled?

Potential for the wire to fracture at the threads and remain in the glenoid.

Which lots are affected?

Catalog Number: 321-52-06, All Serial Numbers

Where was it sold?

US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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