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.
Potential for the wire to fracture at the threads and remain in the glenoid.
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.
The wire can break at the threads during surgery and stay in the glenoid bone. This may cause injury to the patient by remaining inside the shoulder joint.
Surgeons using the Ergo 3.2mm K-wire for shoulder replacements are affected. Patients who have received this device during surgery are at risk of injury if the wire fractures.
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.
Look for the catalog number 321-52-06 on the device packaging or label.
The recall indicates a potential risk of fracture during surgery, so it is not safe to use without recalling the device.
Check for the catalog number 321-52-06 on the product. All serial numbers are affected.
The recall does not specify a remedy, so contact Exactech directly for guidance.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0168-2020 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0168-2020 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
