ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGH...
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0147-2016.
May contain small amounts of ethylene glycol residue
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0147-2016.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Conformis, Inc. or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0147-2016.
ConforMIS, Inc.
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Conformis, Inc. Recall FAQ
Conformis, Inc. is the subject of a medical implants safety report: ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGH.... The notice was published on August 31, 2015 by the U.S. Food and Drug Administration (FDA). Approximately 110 units are potentially affected.