Events

Recall of Device Recall Stryker uHead, Ulnar Implant, Standard Stem

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
    71676
  • Event Risk Class
    Class 2
  • Event Number
    Z-2427-2015
  • Event Initiated Date
    2015-06-24
  • Event Date Posted
    2015-08-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-04-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138747
  • 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, wrist, hemi-, ulnar - Product Code KXE
  • Reason
    Stryker is recalling rhead, uhead, sigmoid notch, remotion, radio capitellum because packaging integrity (sterile barrier) of the packaging type kit i may potentially be compromised by transportation.
  • Action
    Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.

Device

Device Recall Stryker uHead, Ulnar Implant, Standard Stem
  • Model / Serial
    Part Number: UHA-S1 (Ulnar Stem Implant #1 Sterile Packed) - Lot #'s 17584, 17585, 22217301, 22217302, 23470801, 19066-S2, 19417-S2, 19418-S2, 1973-S2, 19732-S2, 19785-S2, 19815-S2 and $23470801; Part Number: UHA-S120 (Recon Ulnar Stem Implant #1, 20mm Extension) - Lot #'s 16725, 16726, 18577, 18757, 18758, 18759, 18867, 23124001, 19056-S2, 19786-S2, 19816-S2, 19928-S2 and 19929-S2; Part Number: UHA-S2 (Ulnar Stem Implant #2 Sterile Packed) - Lot #'s 16714, 16715, 18760, 22760101, 22760102, 23124101, 23124102, 23470901, 19669-S2, 19817-S2, 19866-S2 and R23470901; Part Number: UHA-S220 (Recon Ulnar Stem Implant #2, 20mm Extention) - Lot #'s 16720, 16721, 18415, 18761, 18762, 18763, 18764, 18765, 18868, 23124201, 19122-S2, 19787-S2, 19818-S2, 19930-S2 and 19932-S2; Part Number: UHA-S3 (Ulnar Stem Implant #3 Sterile Packed) - Lot #'s 16716, 16717, 22760201, 22760202, 22760203, 23124301, 23124302, 19788-S2, 19789-S2, 19818-S2, 19820-S2, 19821-S2, 19867-S2 and 19868-S2; Part Number: UHA-S320 (Recon Ulnar Stem Implant #3, 20mm Extention) - Lot #'s16722, 16723, 18869, 19065-S2, 19157-S2, 19733-S2, 19790-S2 and 19933-S2; Part Number: UHA-S4 (Ulnar Stem Implant #4 Sterile Packed) - Lot #'s 16718, 16719, 18766, 18865, 18866, 19156-S2, 19670-S2, 19671-S2, 19672-S2, 19734-S2, 19822-S2 and 19869-S2; Part Number: UHA-S420 (Recon Ulnar Stem Implant #4, 20mm Extention) - Lot #'s 16724, 18578, 18767, 18768, 18870, 18871, 22760301, 19072-S2, 19100-S2, 19158-S2, 19791-S2, 19823-S2, 19934-S2 and 19935-S2
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    uHead, Ulnar Implant, Standard Stem, Size 1, Sterile, Rx Only. Intended for replacement of the distal radioulnar joint following ulnar head resection arthroplasty.
  • 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