Arthrex, Inc. recalls iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right
See all recalls from Arthrex, Inc. →Recalled 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 painful osteoarthritis or posttraumatic arthritis. 2. Correction of functional deformity. 3. Revision of previous unsuccessful uni-compartmental knee replacement or other procedure. 4. As an alternative to tibial osteotomy in patients with uni-compartmental osteoarthritis.
Hazard / Issue
Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 printed on the patient label inside the box.
Issued by
FDA
✅ What Should You Do?
- 1Contact your healthcare provider immediately to discuss this recall.
- 2Stop using the device if it is safe to do so, and contact your provider.
- 3Follow the manufacturer's remedy instructions provided in the recall notice.
- 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.
Looking for a safe alternative?
Search Amazon for iBalance(R) UKA, Femoral Cemented, →If you were harmed by this recalled product, Top Class Actions lists active class action lawsuits and settlements that may apply to you.
Get the next US recall alert before it hits the news.
Free. Weekly digest or instant alerts. Unsubscribe anytime.
CAN-SPAM compliant · No spam · Unsubscribe anytime