Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0236-2016 — Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.

U.S. FDA — Device Enforcement · United States · 2015-10-08 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0236-2016
Date of alert
2015-10-08
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Synthes (USA) Products LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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