FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
- Recall number
- Z-2056-2017
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
- Status
- Terminated
- Initiated
- 2017-04-13
- Posted
- 2017-04-25
- Terminated
- 2019-03-26
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 4238
- Distribution
- TX. Japan Mexico
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K051496","K091908"]
- PMA numbers
- not on file
- Product code
- LOD
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28