Date Initiated by Firm |
December 23, 2019 |
Create Date |
February 04, 2020 |
Recall Status1 |
Terminated 3 on September 10, 2020 |
Recall Number |
Z-0988-2020 |
Recall Event ID |
84679 |
Product Classification |
Instrument, biopsy - Product Code KNW
|
Product |
Jamshidi Bone Marrow Aspiration Needle
Item Number: 00-1103-007-00 |
Code Information |
Lot Numbers : 62754464, 62904231, 63060634 |
Recalling Firm/ Manufacturer |
Zimmer Biomet, Inc. 1800 W Center St Warsaw IN 46580-2304
|
For Additional Information Contact |
411 Technical Services 574-371-3071
|
Manufacturer Reason for Recall |
Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
|
FDA Determined Cause 2 |
Packaging process control |
Action |
Zimmer Biomet issued Urgent Device Recall dated 12/23/19, to Distributors/Hospitals via email/courier stating reason for recall, health risk and action to take: Distributors responsibilities- locating and removing the product in their territory, as well as identifying hospitals and surgeons who have previously used the product.
Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter.
Hopsitals:
Review this notification and ensure that affected personnel are aware of the contents, including surgeons that utilized this product.
If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility.
Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com.
Questions or concerns call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com |
Quantity in Commerce |
133 units |
Distribution |
US Nationwide |
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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