Exactech, Inc. Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments. Recall
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization and stabilization of spinal segments.
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
Catalog Number 28202, Lot Number AS05107
Products Sold
Catalog Number 28202, Lot Number AS05107
Exactech, Inc. is recalling Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to p due to Incorrect thread form on the screw.. This is a Class I recall, indicating a high risk of serious health consequences or death. Based on FDA medical device enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect thread form on the screw.
Recommended Action
Per FDA guidance
Healthcare providers and patients should stop using the device and contact the manufacturer for further instructions. Report problems to FDA MedWatch.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
FL, GA, IL, IN, NY, TX, WA
Page updated: Jan 11, 2026