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U.S. Department of Health and Human Services

Class 2 Device Recall Jamshidi Bone Marrow Aspiration Needle

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 Class 2 Device Recall Jamshidi Bone Marrow Aspiration Needlesee related information
Date Initiated by FirmDecember 23, 2019
Create DateFebruary 04, 2020
Recall Status1 Terminated 3 on September 10, 2020
Recall NumberZ-0988-2020
Recall Event ID 84679
Product Classification Instrument, biopsy - Product Code KNW
ProductJamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
Code Information Lot Numbers : 62754464, 62904231, 63060634
FEI Number 1000220733
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
1800 W Center St
Warsaw IN 46580-2304
For Additional Information Contact411 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
ActionZimmer 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 Commerce133 units
DistributionUS Nationwide
Total Product Life CycleTPLC 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.
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