Events

Recall of Solitaire35

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

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
    65043
  • Event Risk Class
    Class 2
  • Event Number
    Z-2292-2013
  • Event Initiated Date
    2013-04-09
  • Event Date Posted
    2013-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117781
  • 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
    Intervertebral fusion device with bone graft, lumbar - Product Code MAX
  • Reason
    Several complaints were recorded regarding one of the three screws driving through the cage of the solitaire 35 implant.
  • Action
    Biomet LLC sent "Urgent Medical Device Recall" letters/fax back response forms on Tuesday April 9, 2013 via Fed Ex to all distributors. The notification identified the problem, product involved, and risk factors. In addition, the notification provides instructions to the representatives on how to return the product to EBI, LLC. Surgeons that have implanted the product were contacted on April 12, 2013.

Device

Solitaire35
  • Model / Serial
    14-535140 12 mm 6-deg narrow 2327561 October-22 2302271 April-22  14-535141 14mm 6-deg narrow 2327661 November-22 2302281 April-22  14-535142  16mm 6-deg narrow 2327691 December-22 2302291 April-22  14-535143 18 mm 6-deg narrow  2327701 December-22 2302301 April-22  14-535144  20mm 6-deg narrow 2327711 December-22 2302301 April-22  14-535144 20 mm 6-deg narrow 2302311 June-22  14-535150  12mm 12-deg narrow 2327711 December-22 2302321 April-22  14-535151 14mm 12-deg narrow 2327601 October-22 2302332 April-22   14-535152 16mm12-deg narrow  2327671 November-22 2302341 April-22  14-535153 18 mm 12-deg narrow  2327751 December-22 2302351 April-22  14-535154 20 mm 12-deg narrow 2327571 December-22 2327571 November-22 2302361 April-22  14-535170 12mm 6-deg medium  2327631 October-22 2302371 April-22  14-5351711  14 mm 6-deg medium 2327641 October-22 2302381 April-22  14-535172 16 mm 6-deg medium 2327761 December-22 2302391 April-22  14-535173  18 mm 6-deg medium  2327771 Dec 22 2302401 April 22  14-535174  20 mm 6-deg medium 2302411 April-22  14-535180 12mm 12-deg medium 2327621 October-22 2302421 April-22  14-535180 12 mm 12-deg medium 2327621 October-22 2302421 April-22  14-535182 16mm 12-deg medium 2327651 October 22 2302441 April 22  14-535183  18 mm 12-deg medium  2302451 April-22  14-535184 20 mm 12-deg medium  2327581 October-22 2302461 April-22  14-535200 12 mm 6-deg wide 2302471 April-22  14-535201  14mm 6-deg wide 2327721 December-22 2302481 April-22  14-535202  16 mm 6-deg wide  2327591 October-22 2302491 March-22  14-535203 18 mm 6-deg wide 2328311 October-22 2302501 April-12  14-535204  20 mm 6-deg wide 2302511 April-22   14-535210 12 mm 12 deg wide 2302521 April 22  14-535211 14 mm 12-deg wide 2327681 Decembr-22 2302531 April-22  14-535212 16 mm 12-deg wide 2327731 December-22 2302541 April-22  14-535213 18mm 12-deg wide 2327741 December-22 2302551 May-22
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide distribution: US including states of: CA, GA, IN, KY, MO, NY, OR, TX, and WI.
  • Product Description
    Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device.
  • Manufacturer
    Ebi, Llc

Manufacturer

Ebi, Llc
  • Manufacturer Address
    Ebi, Llc, 399 Jefferson Rd, Parsippany NJ 07054-3707
  • Manufacturer Parent Company (2017)
    Zimmer Biomet Holdings
  • Manufacturer comment
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA