Exactech 2.4mm x 2.5 Fluted Pin Pouch Recall: May Contain Only One Pin
Exactech recalls 2.4mm x 2.5 Fluted Pin Pouch (Catalog 351-90-22) used in ankle surgery. The pouch may contain only one pin instead of four, risking improper implantation. Affected units have specific serial numbers and packaging lots.
Lower-risk recall
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Contact the company
What happened, in plain English
Exactech recalls a specific surgical pin pouch used in ankle replacements. It may contain only one pin instead of four, which could lead to improper implantation. This is a safety issue for surgeons using the product. Read more at govinfonow.com/recall/66919-exactech-2-4mm-x-2-5-fluted-pin-pouch-recall.
Source Summary by GovInfoNow · govinfonow.com/recall/66919-exactech-2-4mm-x-2-5-fluted-pin-pouch-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0361-2020
Cite this page
“Exactech 2.4mm x 2.5 Fluted Pin Pouch Recall: May Contain Only One Pin.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66919-exactech-2-4mm-x-2-5-fluted-pin-pouch-recall. Based on FDA recall #Z-0361-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0361-2020%22&limit=1).
Why it’s dangerous
The pouch is designed to hold four pins but may contain only one. This could lead to improper implantation of the ankle replacement system, potentially causing complications during surgery.
Who’s affected
Surgeons who use the Exactech 2.4mm x 2.5 Fluted Pin Pouch (Catalog 351-90-22) for ankle replacements are affected. The risk is low as this is a single-use surgical instrument with a specific manufacturing batch.
How to tell if you have this one
Check for the catalog number 351-90-22 on the pouch. Affected units have serial numbers starting with 6189213 and packaging lots 49079322 or 49079321.
- Brand
Exactech- Category
Medical device
What to do — step by step
Check Pouch Contents
Verify the pouch contains four pins as intended; if only one pin is present, it is affected.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 4 states.
FDA distribution: “US Nationwide distribution in the states of GA, NY, OH, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Georgia, New York, Ohio, Virginia.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are there specific serial numbers for affected units?
Yes, affected units have serial numbers starting with 6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, or 6189273.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0361-2020 (October 2, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0361-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.