Date Initiated by Firm |
June 04, 2019 |
Create Date |
July 12, 2019 |
Recall Status1 |
Terminated 3 on July 21, 2021 |
Recall Number |
Z-1962-2019 |
Recall Event ID |
83085 |
510(K)Number |
K031280
|
Product Classification |
Instrument, surgical, sonic and accessory/attachment - Product Code JDX
|
Product |
Ultra-Drive Hose/Drape Assembly, Reference Number 423833 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications. |
Code Information |
Lot Numbers: 221437 211324 211638 212670 212877 213350 213612 214315 214545 214994 216550 216610 217760 217766 218921 219825 |
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 |
The products do not have sufficient data to support the labeled shelf life of 10 years.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers. |
Quantity in Commerce |
8478 total |
Distribution |
Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
510(K) Database |
510(K)s with Product Code = JDX and Original Applicant = BIOMET, INC.
|