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…

Recall date

December 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1195-2016

FDA classification

Class II

Brand / firm

Arthrex, Inc.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).