Events

Recall of Device Recall Equinoxe Reverse Shoulder Fracture Adapter Tray Screw

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
    62566
  • Event Risk Class
    Class 2
  • Event Number
    Z-2118-2012
  • Event Initiated Date
    2012-06-15
  • Event Date Posted
    2012-07-31
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111065
  • 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, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
  • Reason
    Exactech, inc. initiated a recall of equinoxe replicator plates, equinoxe locking screws, equinoxe compression screw kits, equinoxe fracture adapter tray screws, and octane-c intervertebral fusion devices due to the firm determining that the device labeling identifies the affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year.
  • Action
    Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832. For questions regarding this recall call 352-377-1140.

Device

Device Recall Equinoxe Reverse Shoulder Fracture Adapter Tray Screw
  • Model / Serial
    Catalog Number 324-11-00  Serial Range 1653706-2381151
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
  • Product Description
    Equinoxe Reverse Shoulder Fracture Adapter Tray Screw || Intended for Primary and Reverse Total Shoulder Arthroplasty.
  • 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