Conformis recalls iTotal Posterior Stabilized knee replacement systems with mismatched labeling on boxes and pouches. Affected units include specific catalog and serial numbers. Consumers should contact Conformis for details.
The labeling of the boxes and sterile pouches did not match the contents.
Conformis is recalling certain iTotal Posterior Stabilized knee replacement systems due to mismatched labeling on boxes and sterile pouches. This could lead to incorrect surgical procedures if the wrong parts are used. The recall affects specific catalog and serial numbers.
The labeling on the product boxes and sterile pouches does not match the actual contents. This mismatch could result in surgeons using the wrong parts during knee replacement surgery, potentially causing incorrect procedures or complications.
Patients who received the recalled iTotal PS knee replacement systems with specific catalog number TPS-111-1111 and serial numbers 0434436 or 0434836 are affected. Surgeons and medical facilities using these units are at risk of using incorrect parts during surgery.
Check for catalog number TPS-111-1111 and serial numbers 0434436 or 0434836 on the product box or sterile pouch. The recall applies to specific units sold with these identifiers.
Reach out to Conformis directly for information about the recalled units and next steps.
The recalled model is iTotal Posterior Stabilized (PS) Knee Replacement System with catalog number TPS-111-1111 and serial numbers 0434436 or 0434836.
Check the catalog number on the product box or sterile pouch for TPS-111-1111 and serial numbers 0434436 or 0434836.
Contact Conformis directly for information about the recalled units and next steps.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1079-2019 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1079-2019 from Conformis. 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.
