Exactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Error
Exactech is recalling 11 Vantage Total Ankle Tibial Inserts because the labels incorrectly identify the implant size as 3 instead of 4.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a minor labeling error regarding size identification, which aligns with the rubric criteria for moderate severity.
Plain-English summary
Exactech, Inc. is recalling 11 units of the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm. The recall was initiated because a labeling error was identified on the product.
The upper right corner of the label incorrectly identifies the implant size as 3, whereas the actual implant size is 4. The affected units are identified by Catalog Number 350-22-44, Lot numbers 05144883 and 05144884, and specific serial numbers listed in the agency record.
The products were distributed domestically to Colorado, Florida, Oklahoma, and Pennsylvania, as well as internationally to Chile. Consumers and healthcare providers should verify the specific lot and serial numbers of their implants against the recall notice to determine if they are affected.
The recalled product
- Product
- The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
- Manufacturer
- Exactech, Inc.
- Hazard
- Affected units
- 11
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 (10)
- 6417989
- 6417996
- 6417997
- 6417998
- 6418002
- 6418003
- 6488668
- 6488673
- 6488674
- 6488675.
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 · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateExactech Recalls Vantage Total Ankle Tibial Inserts Due to Labeling Mismatch
FDA (Devices) · 2017-12-13
- ModerateExactech Vantage Total Ankle Tibial Insert Recalled for Labeling Mismatch
FDA (Devices) · 2017-12-13
- ModerateExactech Recalls Tibial Alignment Guides Due to Incorrect GTIN Labeling
FDA (Devices) · 2018-09-12
- HighExactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss
FDA (Devices) · 2023-12-27
- ModerateExactech Recalls Truliant Splined Stem Extensions Due to Labeling Error
FDA (Devices) · 2020-03-04
- HighExactech Recalls Optetrak Logic Tibial Inserts Due to Dimensional Defects
FDA (Devices) · 2012-09-12