Wright Medical recalls INBONE Total Ankle System (Model 220222210E) due to mismatched package contents and labeling. Affected units sold with specific lot codes.
The package contents and package labeling do not match.
Wright Medical is recalling the INBONE Total Ankle System (Model 220:22210E) because the package contents and labeling do not match. This mismatch could lead to incorrect use or improper installation, which may affect surgical outcomes.
The package contents and labeling do not match, meaning the actual components delivered may differ from what is labeled. This could result in using the wrong implant parts during surgery, potentially causing complications or improper healing.
Orthopedic surgeons and medical professionals who use the INBONE Total Ankle System for surgical procedures. Patients receiving this implant are at risk if the incorrect components are used.
Check for the model number 220222210E and lot code 05113580751661825 on the packaging. The product was sold with this specific GTIN: 00840420124968.
Verify the model number 220222210E and lot code 05113580751661825 on the packaging to confirm it matches the recalled item.
The package contents and labeling do not match, which could lead to incorrect use or improper installation during surgery.
The recall does not specify a remedy, so check the package details to confirm if it matches the recalled model and lot code.
The recall states a mismatch in package contents and labeling, but no specific injury risk is mentioned. This is considered a low-risk issue for surgical procedures.
We’ve drafted a message you can send Wright Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0315-2022 — Wright Medical Wright Medical Hello, I own a Wright Medical that is covered by recall Z-0315-2022 from Wright Medical. 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.