This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

Revitan Proximal Stems (2016-03-17)

Starting date:
March 17, 2016
Posting date:
March 29, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57696

Affected products

  1. REVITAN PROXIMAL SPOUT STEMS
  2. REVITAN PROXIMAL CYLINDRICAL STEMS

    Reason

    Zimmer GMBH is initiating a voluntary recall of certain batches of Revitan proximal spout stems and Revitan proximal cylindrical stems because the thread spacing of the products may be out of specification. This may make use of the Revitan modular impactor (ref 01.00409.800) difficult or even impossible.

    Affected products

    A. REVITAN PROXIMAL SPOUT STEMS  

    Lot or serial number

    More than 10 numbers, contact manufacturer.

    Model or catalog number

    01.00401.055
    01.00401.065
    01.00401.075
    01.00401.085
    01.00401.095
    01.00401.105

    Companies
    Manufacturer
    Zimmer GmbH
    Sulzer Allee 8,
    Winterthur
    8404
    SWITZERLAND

    B. REVITAN PROXIMAL CYLINDRICAL STEMS

    Lot or serial number

    More than 10 numbers, contact manufacturer.

    Model or catalog number

    01.00402.055
    01.00402.065
    01.00402.075
    01.00402.085
    01.00402.095
    01.00402.105

    Companies
    Manufacturer
    Zimmer GmbH
    Sulzer Allee 8,
    Winterthur
    8404
    SWITZERLAND