Unity Total Knee System Inserts May Be Mislabeled With Wrong Size
Corin Ltd is recalling Unity Total Knee System inserts due to a labeling mix-up between batches 529803 and 532405, potentially affecting size 6 and size 7 designations.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The labeling error involves surgical implants where incorrect sizing creates risk of harm, qualifying as a 'risk-of-harm product where injury has not yet been reported' per the severity rubric.
Plain-English summary
Corin Ltd is recalling the Unity Total Knee System (Model 112.001.34) due to a labeling error affecting two production batches. Unity CR Inserts from batch 529803 may be incorrectly labeled as batch 532405, and vice versa, creating potential confusion between size 6 and size 7 designations. The affected units were distributed in Michigan, Texas, and Illinois.
The labeling error creates risk that the incorrect size insert could be implanted during knee replacement surgery. In surgical applications, receiving the wrong size component could result in improper fit and function of the implant.
Patients who have undergone or will undergo knee replacement surgery should contact their healthcare provider to confirm they received the correct component size. Healthcare facilities should review inventory of batches 529803 and 532405 and cross-reference batch numbers with size labels before use. The affected product is identified by UDI/DI 05055343872505.
The recalled product
- Product
- Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty
- Manufacturer
- Corin Ltd
- Category
- Medical Device — Knee Implant
- Hazard
- labeling-error
- sizing-mismatch
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 (2)
- UDI/DI 05055343872505
- Lot Number 532405.
Distribution
Distributed in 3 states:
- IL
- MI
- TX
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