Exactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
Exactech is recalling 537 Optetrak Offset Tibial Trays and Screws due to a design incompatibility with certain offset spine stiffener screws and constrained condylar tibial inserts.
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. Per the rubric, FDA Class II recalls with potential for adverse health consequences or significant injury reports are rated as Severe (4).
Plain-English summary
Exactech, Inc. is recalling 537 units of the Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44. The devices are sterile and require a prescription. The recall covers all lot numbers of this specific product configuration.
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, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The affected devices were distributed to hospitals and medical facilities in 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 should stop using the affected devices and contact Exactech for instructions on return or replacement.
The recalled product
- Product
- Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 537
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 →- SevereCompass 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
- HighExactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- HighExactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
FDA (Devices) · 2017-11-29
Similar recalls
- HighExactech Recalls Optetrak Proximal Tibial Spacers Due to Dimensional Incompatibility
FDA (Devices) · 2012-08-29
- ModerateExactech Recalls Optetrak Tibial Trays Due to Potential Mislabeled Components
FDA (Devices) · 2012-08-01
- ModerateExactech Recalls Optetrak Knee Trays Due to Potential Mislabeled Components
FDA (Devices) · 2012-08-01
- HighExactech Recalls Optetrak Logic Tibial Inserts Due to Dimensional Defects
FDA (Devices) · 2012-09-12
- ModerateExactech Recalls Mismarked Truliant Tibial Fit Trays for Knee Replacement
FDA (Devices) · 2019-05-01
- SevereExactech Recalls Knee Prosthesis Spacers Due to Dimensional Mismatch
FDA (Devices) · 2013-03-27