Recall Z-1963-2019 ยท JDX Instrument, Surgical, Sonic And Accessory/Attachment
Zimmer Biomet, Inc.
Ultra-Drive Irrigation Tubing Assembly, Reference Number 423834 - Product Usage: Item used with the UltraDrive System to provide proper irrigation during the cutting and removal of bone and acrylic bone cement in orthopedic applications.
| Date | Jun 4, 2019 |
| Status | Terminated |
| Reason | The products do not have sufficient data to support the labeled shelf life of 10 years. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 6/4/19 were sent to customers. |
| Quantity | 8478 total |
| Distribution | Worldwide distribution - US nationwide distribution and countries of Australia, Brazil, Canada, Chile, China, Columbia, Hong Kong, India, Japan, Malaysia, Netherlands, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031280 | ULTRA-DRIVE 3 Biomet, Inc., Sep 22, 2003 |