Events

Recall of Stryker

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    72381
  • Event Risk Class
    Class 2
  • Event Number
    Z-0249-2016
  • Event Date Posted
    2015-11-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140853
  • 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, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
  • Reason
    Stryker is recalling various lots of the trithion mis modular distal capture because complaints were received that specific lots of this product may disassociate during use.
  • Action
    Stryker notified their Branches/Agencies of this recall by email on September 29, 2015 and notifiction letters and product accountability forms were sent via UPS (with return receipt) on September 29, 2015 to branches and on September 30, 2015 to hospitals. Stericycle wil be handling the returns. Customers with questions were instructed to call 201-831-5826. For questions regarding this recall call 201-831-5272.

Device

Stryker
  • Model / Serial
    Catalog No: 6541-5-723 Lot Nos.: AF1C00, AF1C00A, AF1C00S1, AF1C11, AF1C11A, AF1C11AR, AF1C11AR1, AF1C11J, AF1C11JR, AF1C11M, AF1C11MT, AF1C11X1, AF1C12, AF1C12R, AF1E01, AF1E01D, AF1E01D1, AF1E01D1R, AF1E01M, AF1E01MR, AF1E01MR1, AF1E01MX1, AF1E01MX2, AF1E01MX2R, AF1E01MX3, AF1E01R, AF1E01R1, AF1E07, AF1E08, AF1K14, AF1K14R, AF1T43, AF1W33, AF1W34, AF1W36, AF2C11, AF2C11A, AF2C11G, AF2C11R, AF2C12, AF2C12A, AF2C12A1, AF2C12R, AF2C53, AF2C53A, AF2C58, AF2C58M, AF2C58R, AF2S08, AF3L05, AF3L05P, AF3S11, AF3T02, AF3T02J, AF3V02, AF3V02J, AF3V09, AF3V09A, AF3W04, AF3W04D, AF3W29, AF3W29D, AF3W29X1, AF4C07, AF4C07M, AF4C07P, AF4C07X1, AF5A01, AF5A02, AF5A03, AF5K00, AF5S00, AF5S00T, AF5V01, AF5V01H, AF6E03, AF6E03N, AF6E03T, AF6E03TE, AF6E04, AF6E04J, AF6E04N, AF6K00, AF6K00A, AF6K00D, AF6K00L, AF6K05, AF6K05D, AF6K05H, AF6K05X, AF7A00, AF7A00L, AF7C01. AF7C01E, AF7E00, AF7H01, AF8S00, AF8V03, AF8V03A, AF8W00, AF9E00, AF9L00, AF9L00A, AF9N00, AF9T00, AF9T00E, AFZV06, AFZV18, AFZV18A, AFZV18R, AFZW21, AFZW21A, AFZW22, AFZW23, AFZW23A, AFZW23R, AFZW23R1, AFZW23R2, AFZW23W, AFZW23X1 and AFZW23X1R
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI.
  • Product Description
    Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secured to the femoral, the MIS distal capture can optionally be attached to the distal resection guide to complete the cut, per Trithion MIS surgical protocol TRI ATH-SP-5. Surgical instrument for knee prosthesis implantation.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2006
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA