Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech, Inc. is recalling 575 Optetrak Constrained Condylar Offset Screws due to a design incompatibility with certain tibial inserts and trays.
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, which corresponds to a Severe severity score per the rubric.
Plain-English summary
Exactech, Inc. is recalling 575 units of the Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78. 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 an offset tibial tray.
The affected devices were distributed to Alabama, Florida, Indiana, Maine, Minnesota, New Jersey, New York, Ohio, Oklahoma, Virginia, and Puerto Rico. Foreign distribution included Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and the United Kingdom. All lot numbers are affected.
This is a Class II recall. Healthcare providers should stop using the affected devices and contact Exactech, Inc. for further instructions.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 575
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