Recall Z-2056-2017
Zimmer Biomet, Inc. · initiated April 13, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
Codes / lots: 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
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.
FDA-determined cause: Under Investigation by firm
Action taken
On 4/13/2017 URGENT MEDICAL DEVICE RECALL LOT SPECIFIC notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Details
- Recall number
- Z-2056-2017
- Initiated
- April 13, 2017
- Posted by FDA
- April 25, 2017
- Terminated
- March 26, 2019
- Product code
- LOD – Bone Cement
- Quantity
- 4238
- Distribution
- TX. Japan Mexico
- Recalling firm
- Zimmer Biomet, Inc., Warsaw, IN