Orthopedic knee implant components mislabeled; size mix-up risk
Corin Ltd recalled 3 Unity CR Femur knee implants due to labeling errors. Size 6 implants from batch 529803 may be labeled as size 7, and vice versa.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 device with labeling error creating a risk of surgical complications. No injuries or hospitalizations have been reported, but size mismatch could compromise the surgical outcome if the wrong implant is inadvertently selected.
Plain-English summary
Corin Ltd has issued a recall of 3 units of Unity CR Femur Right implants (Size 6, Model Number 112.001.32) due to a labeling error. Implants from lot 529803 may be incorrectly labeled as size 7 units from lot 532405, and vice versa.
This labeling confusion poses a risk during knee replacement surgery. If a surgeon selects the implant based on the incorrect label, the patient may receive a component that does not fit properly, potentially affecting the surgical outcome and requiring further intervention.
The affected implants were distributed to healthcare facilities in Michigan, Texas, and Illinois. Healthcare providers who received these devices should verify the actual implant size against the batch information to ensure correct identification during surgery.
The recalled product
- Product
- Unity CR Femur Right, Size 6, Model Number 112.001.32 Primary and revision total knee arthroplasty
- Manufacturer
- Corin Ltd
- Hazard
- Affected units
- 3
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: (05055343872499
- Lot Number: 529803.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Corin Ltd 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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