FDA Medical Device Recalls (openFDA)
Zimmer Biomet, Inc.: Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
- Recall number
- Z-0988-2020
- Recalling firm
- Zimmer Biomet, Inc.
- Product
- Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
- Status
- Terminated
- Initiated
- 2019-12-23
- Posted
- not on file
- Terminated
- 2020-09-10
- Reason
- Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label
- Root cause
- 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
- 133 units
- Distribution
- US Nationwide
- Lot, serial or model codes
- Lot Numbers : 62754464, 62904231, 63060634
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KNW
- Firm FEI
- 1000220733
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28