Recall Z-0236-2016— Synthes (USA) Products LLC

Name: FDA recall Z-0236-2016
Creator: U.S. Food and Drug Administration
Published: 2015-10-08

Class II · Terminated

Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2015-10-08, terminated 2016-07-15. It names one FDA 510(k) clearance: K915818. Product: Synthes Small Notch Titanium Reconstructive Plate set (SNTRP). Ti PLATE/ROD/PLATE 231mm 6HOLES/5.0mm ROD/17HOLES. Orthopedic implant.. Reason: 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..

Recalling firm: Synthes (USA) Products LLC
Classification: Class II
Status: Terminated
Initiated: 2015-10-08
Terminated: 2016-07-15
Firm location: West Chester, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K915818 — SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATESynthes (Usa)·cleared 1992-01-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.