Exactech Recalls Ergo 3.2mm K-wires Due to Fracture Risk
Exactech, Inc. is recalling 158 Ergo 3.2mm K-wires because they may fracture at the threads and remain in the glenoid during shoulder surgery.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (fracture) in a medical device used during surgery, which poses a risk of significant injury or retained foreign material.
Plain-English summary
Exactech, Inc. is recalling 158 units of the Ergo 3.2mm K-wire, catalog number 321-52-06, all serial numbers. The devices are single-use, sterile wires intended for transient use to assist surgeons in implanting Equinoxe Shoulder System components during total shoulder replacement.
The recall is due to a potential for the wire to fracture at the threads and remain in the glenoid. The FDA has classified this as a Class II recall.
The affected devices were distributed nationwide in the United States, including Arkansas, Arizona, California, Colorado, Florida, Illinois, Indiana, Kansas, Louisiana, Minnesota, New York, Ohio, South Carolina, Tennessee, Texas, Virginia, and Washington. Healthcare providers should stop using these devices and contact Exactech, Inc. for instructions on return or replacement.
The recalled product
- 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.
- Manufacturer
- Exactech, Inc.
- Affected units
- 158
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog Number: 321-52-06
- All Serial Numbers
Distribution
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