ConFormis iTotal Knee Replacement System Recalled for Ethylene Glycol Residue
ConforMIS is recalling 110 units of the iTotal Posterior Stabilized Knee Replacement System because they may contain small amounts of ethylene glycol residue.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes the hazard as 'small amounts' of residue without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
ConforMIS, Inc. is recalling 110 units of the ConFormis iTotal Posterior Stabilized Knee Replacement System, specifically the ITOTAL PS-IPOLY-IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT (Catalog Number: TPS1111111). The recall was initiated because the affected implant kits may contain small amounts of ethylene glycol residue.
The affected products were distributed nationwide in the United States, as well as in Germany, Switzerland, and the United Kingdom. The recall covers specific serial numbers for both left and right implant kits, which are listed in the official FDA recall record Z-0147-2016.
Healthcare providers and patients should check their inventory and patient records for the specific serial numbers listed in the recall notice. ConforMIS is the recalling firm responsible for managing the recall process.
The recalled product
- Product
- ConFormis iTotal Posterior Stabilized Knee Replacement System- ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT Catalog Number:TPS1111111
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 110
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by ConforMIS, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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