ConforMIS Recalls Mislabeled Total Knee Replacement Implant Kits
ConforMIS, Inc. is recalling two total knee replacement kits due to mislabeling. The affected units were distributed in California and Texas.
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, but the source text identifies the issue as mislabeling without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity labeling error.
Plain-English summary
ConforMIS, Inc. is recalling two units of Total Knee Replacement kits, Catalog/Model # TPS-111-1111. The recall was initiated because the implant kits were mislabeled. The specific serial numbers for the affected units are 0398482 and 0399917, and the expiration date for these units is 12/31/2017.
The affected products were distributed in the United States to the states of California and Texas. The devices are intended for use as total knee replacements in patients with knee joint pain and disability that cannot be addressed by prosthetic devices treating only one or two knee compartments.
Consumers and healthcare providers who have these specific serial numbers should stop using the devices and contact ConforMIS, Inc. for further instructions on how to return or dispose of the mislabeled kits.
The recalled product
- Product
- Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/ Intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial numbers: 0398482 & 0399917 Expiration Date: 12/31/2017
Distribution
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