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.
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
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.
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.
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.
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.
Verify the pouch contains four pins as intended; if only one pin is present, it is affected.
The pouch may contain only one pin instead of four, which could lead to improper implantation of the ankle replacement system.
Check if the pouch contains four pins. If it contains only one pin, it is affected and should be used with caution.
Yes, affected units have serial numbers starting with 6189213, 6189221, 6189222, 6189223, 6189228, 6189229, 6189249, 6189262, or 6189273.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-0361-2020 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-0361-2020 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
