Events

Recall of Stryker Orthopaedics

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
    70994
  • Event Risk Class
    Class 2
  • Event Number
    Z-1634-2015
  • Event Initiated Date
    2014-08-15
  • Event Date Posted
    2015-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-01-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135949
  • 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
    The peel strength of the inner blister may have been below internal validated requirements. the strength of the seal is directly related to long term shelf life of the sterile barrier.
  • Action
    The firm, Stryker Orthopaedics, notified their Branches/Agencies via email on 8/15/2014 and sent an "Urgent Product Recall" letter dated 8/15/2014 with a Product Recall Acknowledgement Forms to their Branches/Agencies and consignees. The letter describes the product, issue, potential hazards and actions to be taken. The consignees were instructed to complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah NJ 07430. If you have any questions, feel free to contact Sr. Regulatory Compliance Specialist to 201-831-5826.

Device

Stryker Orthopaedics
  • Model / Serial
    Item number 26-3005L Lot numbers MNH0ND, MNH3V7, MNH8XR, MNHN0E, MNH6Y5; 70-3003L Lot MNE6NM; 70-3003R Lot MNE963; 70-3007L Lots MNE58K, MNE6HL, MNE8MN, MNEKXP; 70-3007R Lots MNEV2Y, MNEVDV, MNEN3D, MNEX43; 70-3013L Lot MMMXTY; 70-4104L Lots MNE0Y8, MNE2J2, MND743, MNDVDT; 71-3009L Lots MNE12D, MNEALW, MNEEE4, MNEXLK, MNEXV0; 71-3009R Lots MNELHM, MNEYNE; 71-3013L Lot MMR24J; 71-4104L Lot MMAKXS; 71-4503R Lots MMT7P8, MMT8J3, MNDKJ7; 71-4504L Lots MNE5D4, MNEHV1; 71-4504R Lots MND272, MNDD9D, MNEL8W; 71-4505L Lots MMT4KY, MMTPHS, MNAJ78, MNAN2L, MNDP2N; 71-4505R Lots MMTEW1, MNA062, MNANVA; 71-4506L Lots MNAJ1W, MNARAR, MNEL1Y, MNEW53; 71-4507L Lots MMT971, MMT9R5X1, MMTJRT, MNALJA, MND1V8; 71-4507R Lots MNA17E, MND4WP, MNEAAD, MNEM55; 71-4509R Lots MMR2HL, MND9AE; 80-4403L Lots MNE0LE, MNEJ70, MNEK3L; 80-4404R Lot MNHTRK, 80-4405L Lot MNERD1; 80-4405R Lots MNEEND, MNEHNO, MNEK42, MNEMNR, MNEMXH, MNEY4A; 80-4406L Lots MNA4HR, MNEH40, MNE37L, MNE769, MNE9RD, MNEATP, MNEX06, MNEXA8; 80-4407R Lots MNELAL, MNEP9K, MNEPVE; 80-4408L Lot MNEX9T; 80-4409L Lots MNE7H9, MNEDWK, MNEDXN; 80-4409R Lots MNE0R2, MNETXP, MNEVTV; 80-4411L Lots MNEN81, MNEWN4; 80-6404R Lot MNDKD0; 80-6405R Lots MMTA8L, MNA175; 80-6407L Lot MMRV9D; 80-6411L Lot MMP7TS; 81-4404R Lots MNE34H, MNE9WN, MNEKY7; 81-4405L Lots MNE3XK, MNE4OR, MNE473, MNE50T, MNE6A5, MNE7NN, MNE9DD, MNEDX6, MNEJ0N, MNELK5, MNERR2; 81-4405R Lots MNE5PE, MNE5W5, MNEA1T, MNEH09, MNEK9M, MNEP17, MNEPET, MNEPX6, MNER3V, MNEWW7, MNEXDP, MNEXLL, MNEY3R; 81-4406L Lots MNE0J3, MNE5D6, MNEA42, MNEHL1, MNEM0H, MNEMD4, MNEMJ8, MNEMPD, MNENAR, MNEPN6, MNEW72; 81-4406R Lots MNE1XK, MNE5D2, MNEA75, MNED3A, MNEVLY, MNEYHH; 81-4407L Lots MNE127, MNE26L, MNE3KJ, MNE63T, MNE6XK, MNE71T, MNE8PT, MNE996, MNEPYY; 81-4407R Lots MMPE33, MNEOJ9, MNE217, MNE2NH, MNE3MH, MNE525, MNE5YP, MNE6WT, MNE7V2, MNE9J1, MNEA62, MNEAR2, MNEAXJ, MNED83, MNENNE, MNELEP, MNENM4, MNENY7, MNEPEP, MNERAV, MNETYX, MNEVN7, MNEW3Y, MNEW56, MNEWN0, MNEX5E, MNEXV1, MNEXVT, MNEY27, MNEYR6, MNHTW5; 81-4408L Lots MNE2VE, MNEAMY, MNEEM0, MNEYRT, MNEYYK; 81-4408R Lots MNEO89, MNE2A1, MNE4DK, MNE7XV, MNE8N4, MNE9M9, MNEA4T, MNEAJ8, MNEMLA, MNET9J; 81-4409L Lots MNE4W5, MNE93H, MNEEEN, MNEVOY, MNEY57, MNEY74, MNE159, MNE1H2, MNE2DK, MNEM2D, MNENLJ, MNER77, MNEV0J; 81-4411R Lot MMTVXW; 81-4413L Lot MMP0MP; 81-6404R Lot MMTR58; 81-6407L Lot MMTDN7.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.
  • Product Description
    Stryker Orthopaedics Scorpio femoral component. || Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. || For use in total reconstructive replacement of the knee joint.
  • 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