Exactech Spine Set Screw Recalled for Incorrect Thread Form
Exactech, Inc. is recalling 749 Altiva Large Set Screws due to incorrect thread form. The devices were distributed in six states.
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 3/5 (High).
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 involves a structural defect (incorrect thread form) in a spinal implant, which poses a risk of harm, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Exactech, Inc. is recalling 749 units of the Altiva Large Set Screw, Catalog Number 28202, Lot Number AS05107. These medical devices are intended to provide immobilization and stabilization of spinal segments.
The recall was initiated because the screws have an incorrect thread form. The affected devices were distributed in the states of Florida, Georgia, Illinois, New York, Texas, and Washington.
Healthcare providers and patients should contact Exactech, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 749
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 28202
- Lot Number AS05107
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 · structural defect
See all →- SevereSubaru Recalls 2026 Forester and Crosstrek for Ball Joint Defect
NHTSA · 2026-10-19
- SevereVolvo Recalls 2025-2026 VNL Trucks for Loose Structural Bolts
NHTSA · 2026-10-15
- Severe
- SevereVolvo Recalls EX30 and EX30CC Vehicles for Head Restraint Defect
NHTSA · 2026-10-09
- Severe
Similar recalls
- HighExactech Recalls Optetrak Constrained Condylar Offset Screws Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- HighExactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- SevereExactech Recalls Optetrak Offset Tibial Tray 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