This page has been archived on the Web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.

Archived

This page has been archived on the Web.

Health product recall

ATTUNE Tibial Articulation Surface Instruments (2015-06-16)

Starting date:
June 16, 2015
Posting date:
July 8, 2015
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-54104

Recalled Product

  1. ATTUNE CONV FB PS TB TRIAL
  2. ATTUNE CONV RP PS ARTICULATION SURFACE
  3. ATTUNE CONV RP PS TB TRIAL
  4. ATTUNE RP CR ARTICULATION SURFACE
  5. ATTUNE CONV FB PS ARTICULATION SURFACE

Reason

DePuy is issuing a device correction for all lots of ATTUNE Tibial Articulation Surface Instruments used in trialing with the ATTUNE knee system. The device correction is being issued due to the potential for the balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments, to become damaged and disassociate (come off). The balseal is constructed from implant grade stainless steel. If the balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation.

Affected products

A.ATTUNE CONV FB PS TB TRIAL

Lot or serial number

>100 NUMBERS, CONTACT MFR

Model or catalog number
  • 254500973
  • 254500974
  • 254500975
  • 254500976
  • 254500977
  • 254500978
Companies
Manufacturer

Depuy (Ireland)

Loughbeg

Ringaskiddy

IRELAND



B. ATTUNE CONV RP PS ARTICULATION SURFACE

Lot or serial number

>100 NUMBERS, CONTACT MFR

Model or catalog number

254500993

254500994

254500995

Companies
Manufacturer

Depuy (Ireland)

Loughbeg

Ringaskiddy

IRELAND



C. ATTUNE CONV RP PS TB TRIAL

Lot or serial number

>100 NUMBERS, CONTACT MFR

Model or catalog number

254500996

254500997

254500998

Companies
Manufacturer

Depuy (Ireland)

Loughbeg

Ringaskiddy

IRELAND



D. ATTUNE RP CR ARTICULATION SURFACE

Lot or serial number

>100 NUMBERS, CONTACT MFR

Model or catalog number

2545-00-563

2545-00-564

2545-00-565

2545-00-566

2545-00-567

2545-00-568

Companies
Manufacturer

Depuy (Ireland)

Loughbeg

Ringaskiddy

IRELAND



E. ATTUNE CONV FB PS ARTICULATION SURFACE

 

Lot or serial number

>100 NUMBERS, CONTACT MFR

Model or catalog number

2545-00-504

2545-00-505

2545-00-506

2545-00-507

2545-00-508

2545-00-523

2545-00-524

2545-00-525

2545-00-526

2545-00-527

2545-00-528

2545-00-543

2545-00-545

2545-00-546

2545-00-547

2545-00-548

2545-00-961

2545-00-962

2545-00-971

2545-00-972

2545-00-979

2545-00-980

2545-00-981

2545-00-982

2545-00-991

2545-00-992

2545-00-999

2545-00503

2545-01-000

2545-01-969

2545-01-970

2545-01-989

2545-01-990

2545-01963

2545-01964

2545-01965

2545-01966

2545-01967

2545-01968

 

Companies
Manufacturer

Depuy (Ireland)

Loughbeg

Ringaskiddy

IRELAND


Date modified: