Date Initiated by Firm | April 13, 2017 |
Date Posted | April 25, 2017 |
Recall Status1 |
Terminated 3 on March 26, 2019 |
Recall Number | Z-2056-2017 |
Recall Event ID |
77116 |
510(K)Number | K051496 K091908 |
Product Classification |
Bone cement - Product Code LOD
|
Product | Cobalt HV Bone Cement
Cobalt MV Bone Cement
Cobalt HV Bone Cement With Gentamicin |
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 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
|
For Additional Information Contact | 411 Technical Services 574-371-3071 |
Manufacturer 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 2 | 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 in Commerce | 4238 |
Distribution | TX.
Japan
Mexico |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = LOD 510(K)s with Product Code = LOD
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