—#154987

Product

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

FDA product code: LOD — Bone Cement
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K051496, K091908
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: TX. Japan Mexico

Timeline

Recall initiated: 2017-04-13
Posted by FDA: 2017-04-25
Terminated: 2019-03-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154987. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.