Use cautionMedical device recall · FDA · Published September 10, 2019
Exactech Ergo 3.1mm K-wire Recall: Fracture Risk in Shoulder Surgery
Exactech recalls Ergo 3.2mm K-wire for potential fracture risk during shoulder surgery. The wire may break and stay in the glenoid, causing injury. Affected units include all serial numbers with catalog number 321-52-06.
Exactech recalls its Ergo 3.2mm K-wire surgical device because it can fracture during shoulder surgery and remain in the glenoid bone. This poses a risk of injury to patients. The recall affects all units with the catalog number 321-52-06. Read more at govinfonow.com/recall/67058-exactech-ergo-3-1mm-k-wire-recall-fracture-risk-in.
“Exactech Ergo 3.1mm K-wire Recall: Fracture Risk in Shoulder Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67058-exactech-ergo-3-1mm-k-wire-recall-fracture-risk-in. Based on FDA recall #Z-0168-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0168-2020%22&limit=1).
Exactech, Inc. recalled Ergo 3.2mm K-wires on Sept. 10, 2019, due to potential fracture at the threads. The Food and Drug Administration announced the voluntary Class II recall of 158 devices distributed nationwide.
How to tell if you have it
Brand: Exactech
Product: Ergo 3.2mm K-wire
Catalog Number: 321-52-06
Serial Numbers: All Serial Numbers
Quantity: 158 devices
The hazard
The wire may fracture at the threads and remain in the glenoid. The device is used to assist surgeons in implanting Equinoxe Shoulder System components for total shoulder replacement.
Context
GovInfoNow's records show Exactech, Inc. has 34 other recalls on record since June 23, 2017. Other recent recalls of similar products include Equinoxe Ergo Ergo Modular Impactor Handle Recall (Feb. 3, 2026), Equinoxe Ergo Adjustable Angle rTSA Reamer 46mm recall (Sept. 5, 2025), and Exactech Reverse Shoulder Humeral Liners Recall (Aug. 15, 2025).
How to tell if you have this one
Check for the catalog number 321-52-06 on the product. All serial numbers are affected, so any unit with this catalog number is included in the recall.
Brand
Exactech
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the catalog number 321-52-06 on the device packaging or label.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Florida, Illinois, Indiana, Kansas, Louisiana, Minnesota, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0168-2020 (September 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0168-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.