Zimmer Biomet, Inc. recalls Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Lock…

Recall date

December 9, 2015

Source

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

Recall number

Z-0654-2016

FDA classification

Class II

Brand / firm

Zimmer Biomet, Inc.

Sold / distributed

Worldwide Distribution -- USA, including the states of MN, NY, MS, AL, OH, KY, ME, and NM; and, the countries of Taiwan, Korea, Singapore, El Salvador, Uruguay, Czech Republic, France, Italy, Poland, United Kingdom, South Africa, and Slovakia.

Why it was recalled

The product on the package label did not match what was inside the package. The label was for part number 00-4936-011-13 lot number 62968956 while the product inside the package was part number 00-4936-008-07 lot number 62968974.

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

What was recalled

Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight 11 Holes 144mm Length Zimmer Universal Locking System 3.5mm Locking Dual Compression Plate 8 Holes 105mm Length. Indicated for temporary internal fixation and stabilization of osteotomies and fractures.