Arthrex iBalance UKA Knee Implant Recalled for Incorrect Patient Labeling
Arthrex is recalling 20 units of iBalance UKA knee implants due to incorrect part numbers and sizes printed on the patient label.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and packaging labeling error with no reported injuries or illnesses, fitting the criteria for a Low severity score.
Plain-English summary
Arthrex, Inc. is recalling 20 units of the iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL knee implant (part number AR-501-UFLC, batch 10123297). The recall is due to a labeling error where the patient label inside the box incorrectly displays part number AR-501-UFRA and size 1, rather than the correct part number and size 3.
The affected devices were distributed worldwide, including in the United States (specifically SD, NV, NC, CA, MD, AZ, LA, FL, PA, TX, and NY) and internationally to Germany and Poland. The source text does not report any illnesses, injuries, or deaths associated with this labeling error.
Healthcare providers and patients should verify the part number and size on the device packaging against the surgical records. If the incorrect label is present, the device should not be used, and Arthrex should be contacted for instructions on return or replacement.
The recalled product
- Product
- iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R, Arthrex, Inc., Naples, FL Indicated for use in uni-compartmental knee arthroplasty as a result of: 1. Moderately disabling joint disease of the knee resulting from…
- Manufacturer
- Arthrex, Inc.
- Hazard
- Affected units
- 20
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)
- batch 10123297
Distribution
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