DePuy Mitek Tissue Liberator Recalled for Incorrect Labeling
DePuy Mitek is recalling 27 Tissue Liberator instruments labeled as Blade Up instead of Blade Down. The mislabeling could lead to incorrect instrument use during surgery.
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 involves a minor labeling error (configuration mislabeling) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 27 units of the Tissue Liberator -Blade Up (Catalog Number: 214623). These are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine. The recall is due to a labeling error where the instruments were incorrectly labeled as a Blade Up configuration instead of a Blade Down configuration.
The affected units are from Lot number 13A01. The products were distributed worldwide, including in the United States (specifically Kentucky and New Jersey) and internationally to Argentina, Australia, Belgium, Colombia, India, France, Japan, Jordan, Latvia, Israel, Korea, and Great Britain.
Healthcare facilities and consumers should stop using these instruments and contact DePuy Mitek at 508-977-3813 for further instructions regarding the recall.
The recalled product
- Product
- DePuy Mitek Tissue Liberator -Blade Up Catalog Number: 214623 The Reusable Arthroscopy Instruments are reusable, non-powered surgical instruments used during arthroscopic surgery of any joint except the spine.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Hazard
- Affected units
- 27
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)
- Lot number:13A01
Distribution
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