Exactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
Exactech is recalling 643 Optetrak Constrained Condylar Offset Screws because they are incompatible with certain tibial inserts and trays.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a design incompatibility in a medical device where no specific injuries or illnesses are reported in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Exactech, Inc. is recalling 643 units of the Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70. The recall covers all lot numbers of this sterile, prescription-only medical device.
The recall was initiated 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. This incompatibility affects the specific screw size identified in the recall notice.
Distribution of the affected devices was made 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. Healthcare providers and patients should contact Exactech for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 643
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