Z-2056-2017 Class II Terminated
FDA device recall Z-2056-2017 was initiated by Zimmer Biomet, Inc. on April 13, 2017 and is designated Class II. 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. The recall status is terminated (terminated March 26, 2019). Affected quantity: 4238.
Recall Details
- Product Type
- Devices
- Report Date
- May 17, 2017
- Initiation Date
- April 13, 2017
- Termination Date
- March 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4238
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.
Distribution Pattern
TX. Japan Mexico
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