Events

Recall of Device Recall Trident Universal Impactor/Positioner

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
    75077
  • Event Risk Class
    Class 2
  • Event Number
    Z-0060-2017
  • Event Initiated Date
    2016-08-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149317
  • 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
    Impactor - Product Code HWA
  • Reason
    Stryker orthopaedics has received reports of the thread length protruding past the dome of the acetabular trial or implant for the trident universal impactor/positioner.
  • Action
    Stryker sent an Urgent Medical Device Recall Notification dated August 18, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Needed: 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2. Branches/Agencies: Return all affected products available at your location to Stryker C/0 Stericycle 3. Hospitals/Branches: Complete and sign the enclosed Business Reply Form and fax a copy to 877-546-0444 or email to Stericycle strvkerortho6536@stericycle.com. Our records indicate that you have received the above referenced instrument. It is our responsibility to ensure that customers who may have received this affected instrument also receive this important communication. Please assist us in meeting our regulatory obligation by faxing back the attached Business Reply Form within 5 days. We regret any inconvenience this action may cause you and if you have any questions, feel free to contact me at (201) 831-6693. For further questions regarding this recall, please call (201) 831-5000.

Device

Device Recall Trident Universal Impactor/Positioner
  • Model / Serial
    Catalog No: 2101-0200, Lot Nos. SMM7A00, SMM7A00L, SMM7A02, SMM7A02A, SMM7A02E, SMM7A02EE, SMM7A01T, SMM7A01TT, SMM7A01TD, SMM7A01TDD, SMM7C02H, SMM7C02, SMM7C01, SMM7C01T, SMM7C01TT, SMM7C01W, SMM7E03, SMM7E03A, SMM7E00, SMM7A00E, SMM7E02, SMM7E02A, SMM7E01, SMM7E01A, SMM7K00. SMM7K01, SMM7K01A, SMM7K03, SMM7K03L, SMM7K02, SMM7K02T, SMM7K03X, SMM7K03Y, SMM7C02J, SMM7L00H, SMM7L00J, SMM7L00K, SMM7L00, SMM7C01TW, SMM7M01, SMM7A02T, SMM7M00, SMM7M00A, SMM7M02H, SMM7M02, SMM7E02M, SMM7E01JK, SMM7K03J, SMM7K00A, SMM6N04, SMM7N01J, SMM7N01, SMM7M06, SMM7M09, SMM7N03, SMM7N03A, SMM7M06A, SMM7M09, SMM7N00, SMM7M05, SMM7M08A, SMM7M10, SMM7N00A, SMM7N02L, SMM7M05J, SMM7M08, SMM7N02, SMM7N04, SMM7N04J, SMM8C00, SMM7M01R, SMM7M01RW, SMM7M01W, SMM7M07, SMM7M07J, SMM6C00, SMM7M03, SMM7M03A, SMM7M03D, SMM7M03E, SMM7M03L, SMM7M04, SMM7M04L, SMM7M03K, SMM8C00J, SMM8L05, SMM8L05A, SMM8L02X, SMM8L04, SMM6N00, SMM6N01, SMM6N01A, SMM6N02, SMM6N03, SMM6N04A, SMM8L07T, SMM8L08, SMM8M00K, SMM8M00L, SMM8M01, SMM8M01E, SMM8M01EE, SMM8N02, SMM8N02A, SMM8M01A, SMM8N00, SMM8N00A, SMM8N00D, SMM8N01, SMM8N01A, SMM8N01T, SMM8S00, SMM8S00T, SMM8S00TT, SMM8S01, SMM8S01A, SMM8S01D, SMM8T00, SMM8N02T, SMM8S02, SMM8V00, SMM8V00A, SMM8V00E, SMM8T00A, SMM8V01, SMM8V01A, SMM8W02, SMM8W03A, SMM8V02, SMM8W01, SMM8W01A, SMM8W02X, SMM8W03M, SMM8W03P, SMM8W04, SMM8W04A, SMM8W05, SMM8W05A, SMM8W03D, SMM8W03, SMM8W05D, SMM8W00A, SMM8W00E, SMM8W00J, SMM8W00K, SMM8W00, SMM8V02J, SMM8W00D, SMM8V07, SMM8W06H, SMM8W05H, SMM8W00H, SMM8W07, SMM8W07K, SMM8W07L, SMM8W08, SMM8W08E, SMM8W07A, SAMPLE25, SMM8W08EE, SMM9A00, SMM9A00R, SMM9A00T, SMM9A01, SMM9A01E, SMM9A01EL, SMM9A02, SMM9A02E, SMM9A03, SMM9A03K, SMM9A03L, SMM9A03P, SMM8L01, SMM8L03, SMM8L07, SMM8L00T, SMM8L07, SMM9A05, SMM9A06, SMM9A06E, SMM9A07, SMM9A08, SMM9A12, SMM9A12J, SMM9A12T, SMM9A09, SMM9A09K, SMM9A09L, SMM9A10, SMM9A11, SMM9A11D, SMM9A07L, SMM9E01, SMM9E02, SMM9E02A, SMM9E03, SMM9E00, SMM9C00A, SMM9C00D, SMM9C00, SMM9C00J, SMM9C00K, SMM9E05A, SMM9E04, SMM9E04A, SMM9E04D, SMM9E04E, SMM9E05, SMM9E04T, SMM9E04TT, SMM9E06, SMM9E06A, SMM9E06D, SMM9A03HD, SMM9A12X, SMM9H01, SMM9H01A, SMM9H01T, SMM8V01D, SMM8V05, SMM8V06, SMM8V04, SMM8V03, SMM9H00E, SMM9H00EE, SMM9H00K, SMM9H00L, SMM9H00V, SMM9K00, SMM9K01, SMM9K01AT, SMM9K01T, SMM8K01TT, SMM9K02A, SMM9K03, SMM9K02, SMM9K04, SMM9L00, SMM9L01, SMM9L02, SMM9L02A, SMM9L02E, SMM9L02M, SMM9L03, SMM9L03A, SMM9L03D, SMM9L03E, SMM9L04, SMM9L04D, SMM9L04E, SMM9L05, SMM9L04A, SMM9L07, SMM9L07A, SMM9L09, SMM9L09A, SMM9L09D, SMM9V00, SMM9V02A, SMM9V02D, SMM9V05, SMM9V07, SMM9V08A, SMM9A04, SMM9L09E, SMM9L10, SMM9L08, SMM9L08A, SMM9A09P, SMM9K01L, SMM9L06, SMM9M01L, SMM9M01, SMM9M01A, SMM9M03, SMM9M03A, SMMM03D, SMM9M03E, SMM0M02, SMM9M02A, SMM9M02L, SMM9M00, SMM9L10A, SMM9N02M, SMM9N02, SMM9N00, SMM9N00X, SMM9N00Y, SMM9N02K, SMM9N02J, SMM9N01, SMM9N01A, SMM9N01J, SMM9N05A, SMM09N05, SMM9N05D, SMM9N07J, SMM9H01K, SMM9N07JK, SMM9N07N, SMM9T01, SMMN9T01, SMM9T00, SMM0T00A, SMM9T02, SMM8V07A, SMM7E01T, SMM7K01AA, SMM0T00K, SMM9T00J, SMM9T03, SMM9T03A, SMM9T03D, SMM8W01AA, SMM9T03N, SMM9T03L, SMM9T03M, SMM8V01T, SMM8V07T, SMM8W00T, SMM8V03T, SMM8V05T, SMM8V07TT, SMM9V01, SMM9V01A, SMM9V01T, SMM9V01D, SMM9V01J, SMM9V01X, SMM9V00A, SMM9V08, SMM9V08AA, SMM09V06, SMM9V09J, SMM9V04, SMM9V09, SMM9V09A, SMM9V09K, SMM9V03, SMM9V02E, SMM9V02H, SMM9V02K, SMM9V09E, SMM9V09L, SMM9V09LE, SMM9V09LL, SMM9V00HJ, SMM9V00JH, SMM9V00H, SMM9N03, SMM9N04, SMM9N06, SMM9N06A, SMM9N07, SMM09N08, SMM9N08E, SMM9N07A, SMM9N07AA , SMM9N08A, SMM9N08D, SMM9N06T, SMM9N06TA and SMM9N07M
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    US and Internationally
  • Product Description
    Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200, Non-Sterile, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430, USA, A Subsidiary of Stryker Corp.
  • 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