Recall Z-0988-2020 ยท KNW Instrument, Biopsy
Zimmer Biomet, Inc.
Jamshidi Bone Marrow Aspiration Needle Item Number: 00-1103-007-00
| Date | Dec 23, 2019 |
| Status | Terminated |
| 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 |
| Quantity | 133 units |
| Distribution | US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.