Synthes (USA) Products LLC recalls Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Ortho…

Recall date

October 8, 2015

Source

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

Recall number

Z-0236-2016

FDA classification

Class II

Brand / firm

Synthes (USA) Products LLC

Sold / distributed

US Distribution to the states of :MO, NJ, MN, MS, AZ, CA, LA, OK, VA, OH, AR, FL, PA, VT, IN, AL, WA and NY.

Why it was recalled

The Synthes SNTRP set was released for sale as a Trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. In 1999, a module was released containing a small offering of the SNTRP plates. Synthes determined that the product in the SNTRP module is being used in spine surgeries, which are a contraindicated use.

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

What was recalled

Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.