Events

Recall of Device Recall SOL SYS L 9IN CALC 2.25/19.5

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by DePuy Orthopaedics, 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
    63545
  • Event Risk Class
    Class 2
  • Event Number
    Z-0583-2013
  • Event Initiated Date
    2012-12-03
  • Event Date Posted
    2012-12-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-11-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114628
  • 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/polymer, porous uncemented - Product Code LPH
  • Reason
    An engineering analysis has determined the solution calcar stem has the potential to result in impingement with a variety of heads. this impingement may not allow the stem and head to lock as intended. the amount of possible impingement varies depending on the femoral head. worst case condition: calcar stem with -2mm offset articuleze maximum of 0.937mm radial impingement. it is evident that a.
  • Action
    Deputh Orthopaedics sent an Urgent Information - Medical Device Recall Notice dated December , 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. The notification letter instructed consignees to please cease further distribution or use of products immediately. The purpose of the communication was to inform them of this recall and request acknowledgement of receipt of this letter by their facility. Reconciliation forms should be returned to your DePuy Sales Representative or faxed to the following Fax Number: 574-371-4939. For questions regarding this recall call 574-267-8143.

Device

Device Recall SOL SYS L 9IN CALC 2.25/19.5
  • Model / Serial
    Product Code: 157225195 and Lot codes: B2WBP1000, B34H81000, B34H8A000, BB1AJ1000, CD1EX1000, D5NEH1000, X4SF21000, X5FBT1000, X5FBTA000, X5FBV1000, X5FBVA000, X5PGM1000, X5PGN1000, X5PGNA000, X83KD1000, YF3E81000, YF6AF1000, YG4AG1000, ZA7JB1000, and ZA7JBA000.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WY and GUAYNABO, PR
  • Product Description
    SOL SYS L 9IN CALC 2.25/19.5 || Packaging: Product is packed within a poly protector, with protection added as needed for fragile points. The entire stem is then placed within a foam sleeve for added protection. The assembly is then placed and sealed in an inner and outer tray for aseptic transfer. The sealed package is placed into a folding carton, labeled, and shrink wrapped. || Intended Use: SOLUTION System Calcar Stems are used in total hip arthroplasty (THA) to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.
  • Manufacturer
    DePuy Orthopaedics, Inc.

Manufacturer

DePuy Orthopaedics, Inc.
  • Manufacturer Address
    DePuy Orthopaedics, Inc., 700 Orthopaedic Dr, Warsaw IN 46582-3994
  • Manufacturer Parent Company (2017)
    Johnson & Johnson
  • Source
    USFDA