Optipac Bone Cement Recall [Canada]


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Canada/Ottawa: Biomet Orthopaedics Switzerland GmbH certain batch/lots of Optipac Bone Cement due to suspected failure to ensure sterility in a medical device, a serious health and safely hazard. HCSC: http://ht.ly/j3ms306yzkB

Direct link: http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2016/61182r-eng.php

Additional information:
Health Canada/Santé Canada (“HCSC”) reports the following Medical Product is subject to this recall:

  • Optipac Bone Cement with the following model or catalog numbers:
    • 4710500394
    • 4710500394-1
    • 4711500396
    • 4711500396-1
    • 4712500398
    • 4712500398-1

According to Health Canada, Biomet Orthopaedics Switzerland GmbH has recalled all sizes of Optipac Bone Cement manufactured since January 2014. During internal investigation, it was identified that Biomet Orthopaedics cannot guarantee that the sterilization process for the Optipac is fully compliant.

If you believe you have purchased or have in your possession any of the recalled Optipac Bone Cement, please do not use it for a medical procedure. Instead, contact your distributor to return the product.

If you have any questions about this recall notification, please contact the company at Biomet Orthopaedics Switzerland GmbH, Riedstrasse 6, Dietikon, 8953, Switzerland.

Please note: the Canada Consumer Product Safety Act prohibits recalled products from being redistributed, sold or even given away in Canada.

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Additional information about this recall:
HCSC ID number: RA-61182
Recalls Direct RIN: 7916-2016
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