Exactech Recalls Fluted Pin Pouches Due to Potential Quantity Error
Exactech is recalling 2.4mm x 2.5 Fluted Pin Pouches because they may contain one pin instead of four. The recall covers 9 units distributed in four 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 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 the hazard involves a potential quantity error in a surgical instrument. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity recall.
Plain-English summary
Exactech, Inc. is recalling 2.4mm x 2.5 Fluted Pin Pouches, catalog number 351-90-22. These are orthopedic surgical instruments used to assist surgeons in implanting the Vantage Total Ankle System. The recall involves 9 units that were distributed nationwide in Georgia, New York, Ohio, and Virginia.
The recall was initiated because the pouches have the potential to contain a single pin rather than the four pins intended for the procedure. The affected units are single-use, provided sterile, and intended for transient use. Specific serial numbers and lot numbers are listed in the agency's recall record.
Hospitals and surgical facilities should check their inventory for the specific catalog number, serial numbers, and lot numbers associated with this recall. If the affected products are found, they should be removed from use and returned to Exactech, Inc. according to the company's instructions.
The recalled product
- Product
- 2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System - Product Usage: To assist the surgeon in the implantation of Vantage Total Ankle System components according to a conventional…
- Manufacturer
- Exactech, Inc.
- Affected units
- 9
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 (15)
- Catalog Number: 351-90-22
- UDI Number: 10885862567529
- Expiration Date: 08/28/2028
- Serial Numbers (6189213
- 6189221
- 6189222
- 6189223
- 6189228
- 6189229
- 6189249
- 6189262
- 6189273)
- Packaging Lots Numbers (49079322
- 49079321)
- Manufacturing Lot Number:19030412
Distribution
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