Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
Exactech is recalling 57 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
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 agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural or design defects in medical devices that could lead to significant injury.
Plain-English summary
Exactech, Inc. is recalling 57 units of the Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01. The devices are sterile and require a prescription. The recall is being conducted by the U.S. Food and Drug Administration under recall number Z-0126-2018.
The recall is due to a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with the offset tibial tray. This is a Class II recall, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The affected devices were distributed to Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Virginia, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and the United Kingdom. Healthcare providers should contact Exactech for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 57
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 (1)
- All lot numbers
Distribution
Part of a larger recall action
This product is one of 34 recalled by Exactech, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 34 products in this recall →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 · design incompatibility
See all →- HighCompass Health Brands Recalls CPAP Mask Cushions Due to Design Incompatibility
FDA (Devices) · 2018-08-29
- HighExactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- HighExactech Recalls Optetrak Offset Tibial Tray and Screws Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- SevereExactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- HighExactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
FDA (Devices) · 2017-11-29