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Recall Observatory FDA recall evidence

Device product

Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin

Z-2056-2017

April 13, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 77116
Status
Terminated
Classification
Class II
Quantity
4238
Official record key
device-enforcement:Z-2056-2017

Official wording

Reason: Six complaints were filed regarding loss of the Zimmer Biomet applied seal of a sterile Tyvek packaging. A breach in the packaging could lead to loss of sterility of the device.

Code information: Model numbers: 402282 and 402282J - Cobalt HV Bone Cement 402438 - Cobalt MV Bone Cement 402283J - Cobalt HV Bone Cement With Gentamicin 402438 Lot: 507830 402282J Lot: 668140 402282 Lot: 508220 402283J Lot: 189780

Distribution pattern: TX. Japan Mexico

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility