Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Reported: May 17, 2017 Initiated: April 13, 2017 #Z-2056-2017
Product Description
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Reason for Recall
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 4238
- Distribution
- TX. Japan Mexico
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin. Recalled by Zimmer Biomet, Inc.. Units affected: 4238.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 17, 2017. Severity: Moderate. Recall number: Z-2056-2017.
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