Reported Nov 22, 2017 · Terminated
iBalance(R) UKA, Femoral Cemented, Size 3, Left Medial/Right LATERAL, REF AR 501-UFLC, QTY 1, Rx ONLY, STERILE R,…
Arthrex, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Arthrex, Inc. · 1370 Creekside Blvd · Naples, FL · 34108-1945
Is this the product you have?
4 of 4 products
| # | Product as published |
|---|---|
| 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. |
- Lot codes and dates
- batch 10123297
- Amount recalled
- 20 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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