Lactosorb Trauma Plating System

• • Terminated Z-1872-2008 FDA Unclassified (pre-2012) ·initiated 19 Mar 2008 ·on shared 510(k) K955729

  The outer foil pouch on the Lactosorb Plate system was not properly sealed. The product is labeled as sterile, but the lot was not sterilized. These devices are intended to be implanted into bone and are required to be sterile. A heavy bioburden would increase the potential for bone infection (osteomyelitis).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K955729 ↗

FDA Product Code

HRS

FDA applicant

Poly-Medics,Inc.

Device Class

Class II

Regulation

21 CFR Part 888.3030

Advisory Committee

Orthopedic

FDA Decision

SN

• Hard Tissue Replacement (Htr) Granular

  Class II

  FDA 510(k) K934861 Active Cleared 4 Nov 1994

• Lactosorb Suture Anchor

  Class II

  FDA 510(k) K954443 Active Cleared 31 Jan 1996

• Lactosorb Trauma Plating System

  Class II

  FDA 510(k) K960988 Active Cleared 10 Apr 1996

• Lactosorb Pop Rivet

  Class II

  FDA 510(k) K951658 Active Cleared 25 Jul 1995