Events

Recall of Device Recall Novation Crown Cup Connection GXL Neutral Liners

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Exactech, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    64028
  • Event Risk Class
    Class 2
  • Event Number
    Z-0787-2013
  • Event Initiated Date
    2012-11-05
  • Event Date Posted
    2013-02-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115240
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
  • Reason
    Recall of novation crown cup connection gxl neutral liners catalog no. (130-32-53) and novation crown cup connection gxl + 5mm lateralized liners catalog no. (136-32-53). exactech discovered the device labeling was inadvertently transposed.
  • Action
    Exactech, Inc. notified consignees by telephone on 11/05/12 of the affected devices and sent an "IMPORTANT PRODUCT RECALL NOTICE" letter dated 11/06/12. The letter describes the purpose of the recall, the product affected, the problem and actions to be taken by the consignees. A Product Recall Response Form was attached for the consignees to contact the Exactech inventory representative within 5 business days to confirm quantities of product in their inventory and return them to Exactech. Consignees with any questions relating to these devices should call 1-800-392-2832.

Device

Device Recall Novation Crown Cup Connection GXL Neutral Liners
  • Model / Serial
    Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of TN, FL, VA, WA and NV.
  • Product Description
    Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. || Exactech Hip Systems are indicated for use in surgery for hip replacement.
  • Manufacturer
    Exactech, Inc.

Manufacturer

Exactech, Inc.
  • Manufacturer Address
    Exactech, Inc., 2320 NW 66th Ct, Gainesville FL 32653-1630
  • Manufacturer Parent Company (2017)
    Exactech Inc
  • Source
    USFDA