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Arthrex, Inc. recalls Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-5
Recalled March 30, 2016 · FDA recall Z-1195-2016 · Arthrex
Hazard
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface. · FDA Class II
Units
2,378 units.
Sold at
Nationwide Distribution -- AR, AZ, CA, CO, DC, DE, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, NC, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, WA, WI and District of Columbia.
Description
Devices reported to have a smooth texture to the outer surface of the metal, which differed from a previous that had a textured outer surface.
Product
Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC, Size 3 - Catalog # AR-503-TTTD, Size 4 -Catalog # AR-503-TTTE, Size 5 - Catalog # AR-503-TTTF, Size 6 - Catalog # AR-503-TTTG , Size 7 -Catalog # AR-503-TTTH, and Size 8 - Catalog # AR-503-TTTJ. Intended for implantation with bone cement, with the exception of the porous coated femoral components which can be used cemented or uncemented (biological fixation).
Manufacturer(s)
Arthrex, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →