Medical device recalls Moderate risk

Zimmer Biomet, Inc. recalls Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 008…

Recall date
May 18, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2177-2018
FDA classification
Class II
Brand / firm
Zimmer Biomet, Inc.
Sold / distributed
US Distribution to the states of : FL, GA, IN, MA, NM, UT, and WI. Foreign distribution to Canada and Mexico

Why it was recalled

One lot of 75mm tibial tray is potentially etched and labeled as a 79 mm tibial tray. This may lead to delay in surgery, or immediate revision surgery to remove an incorrectly sized tibial component after it has been cemented.

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

What was recalled

Biomet Modular Primary Tibial Tray Implants; Modular Interlok Primary Tray (size 75 mm); Item No. 141215; UDI: (01) 00880304005310 (17) 280306 (10) 385340 Product is used in Total Knee Arthroplasty

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