Zimmer Biomet, Inc. Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label

Recommended Action

Per FDA guidance

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