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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
Related recalls
Same manufacturer · Exactech, Inc.
See all →- HighExactech Ergo modular impactor handle may be missing its cross-pin
FDA (Devices) · 2026-03-18
- HighExactech Equinoxe core instrument kits may have handles missing cross-pins
FDA (Devices) · 2026-03-18
- ModeratePilot tip converters recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamers recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
- ModerateShoulder reamer 46mm recalled after release without completed performance testing
FDA (Devices) · 2025-11-26
Same hazard · fracture
See all →- SeverePenumbra RED 62 Reperfusion Catheter Recalled for Fracture Risk
FDA (Devices) · 2026-10-07
- HighPenumbra System RED 68 Reperfusion Catheter Recall Due to Fracture Risk
FDA (Devices) · 2026-07-29
- HighTangent Single Use Digital Catheter Recalled for Distal Shaft Fractures
FDA (Devices) · 2026-05-27
- SevereHarley-Davidson Sportster S upper triple clamp may fracture during use
NHTSA · 2026-02-09
- Severe
Similar recalls
- ModerateExactech Recalls 30 Equinoxe Shoulder Implants Due to Mislabeling
FDA (Devices) · 2018-02-07
- ModerateExactech Recalls 30 Mislabeled Equinoxe Shoulder Implant Components
FDA (Devices) · 2018-02-07
- HighExactech Orthopedic Surgical Tool Recalled for Fracture Risk
FDA (Devices) · 2018-02-21
- HighExactech Recalls Equinoxe Reverse Shoulder Compression Screw Kits
FDA (Devices) · 2020-10-07
- HighExactech Equinoxe Shoulder System recalled for loss of vacuum
FDA (Devices) · 2023-12-27
- HighExactech Equinoxe Shoulder System recalled for vacuum loss in bags
FDA (Devices) · 2023-12-27