Smith & Nephew Pistons

• 2 recalls, same reason

  • Terminated Z-2814-2020 FDA Class II ·initiated 14 Jul 2020
  • Terminated Z-2813-2020 FDA Class II ·initiated 14 Jul 2020

  Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; see image below

510(k) Number

K003214 ↗

FDA Product Code

ETB

Device Class

Class II

Regulation

21 CFR Part 874.3450

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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See all devices from Gyrus Ent LLC →

• What is the Smith & Nephew Pistons device used for?

  The Smith & Nephew Pistons is a prosthesis designed for partial ossicular replacement in the middle ear. It is used to reconstruct the ossicular chain when one or more of the small bones are damaged or missing, typically due to chronic otitis media, trauma, or congenital defects, to restore conductive hearing function.

• How is the Smith & Nephew Pistons supplied and is it sterile or reusable?

  The Smith & Nephew Pistons is supplied as a sterile, single-use implantable device. It is intended for one-time surgical implantation and must not be resterilized or reused, as doing so could compromise its structural integrity, biocompatibility, and increase the risk of infection or device failure.

• What regulatory pathway was used for the Smith & Nephew Pistons and when was it cleared?

  The Smith & Nephew Pistons received clearance through the FDA’s traditional 510(k) pathway, demonstrating substantial equivalence to a legally marketed predicate device. It was cleared on October 31, 2000, under clearance number K003214, and is classified as a Class II medical device under regulation 874.3450 with product code ETB.