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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

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