Z-0988-2020Class II

Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00

Name: Z-0988-2020 Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
Creator: Zimmer Biomet, Inc.
Published: 2019-12-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2019-12-23 / Terminated / root cause: packaging

FDA source

Zimmer Biomet, Inc. began a recall of Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00 on 2019-12-23. FDA classified it as Class II and gives the reason as "Potential for the expiration date on the outer label that was applied by Zimmer Biomet to exceed the expiration date on the inner label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0988-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-23
Posted: 2020-02-04
Terminated: 2020-09-10
Recalling firm: Zimmer GmbH
Product: Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
Product code: KNW Instrument, Biopsy
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
Root cause tag: packaging
FDA 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 [email protected]. 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 [email protected]
Quantity in commerce: 133 units
Distribution: US Nationwide
Product codes and lots: Lot Numbers : 62754464, 62904231, 63060634

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0988-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0988-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04

Product code KNW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)