Recall Z-1845-2019 ยท LXH Orthopedic Manual Surgical Instrument
Zimmer Biomet, Inc.
Mobi-C 14mm Distraction Screw, Quick Start. Intended for cervical intervertebral disc replacement. Item Number: 0024-LDR TEDAN SURGICAL INNOVATIONS LLC DISTRIBUTED BY: LDR SPINE USA, INC., 13785 RESEARCH BLVD, SUITE 200- AUSTIN, TX 78750 Product Usage: The device is intended as a cervical intervertebral disc replacement at one or two contiguous levels from C3 to C7 designed to maintain/restore se
| Date | Apr 1, 2019 |
| Status | Terminated |
| Reason | Incorrect part description contained on an additional label placed on the packaging: A 14mm length part was incorrectly labeled as being a 12mm length screw |
| Root cause | Labeling mix-ups |
| Action | Zimmer issued letter notification dated 4/1/19 via email and FedX identifying the issue, health risk, and action to take: 1. Review this notification and ensure that affected team members are aware of the contents. 2.Immediately locate and quarantine affected product in your inventory.3.Immediately return all affected product from your distributorship and from affected hospitals within your territory. Complete Attachment 1 Inventory Return Certification Form4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com. If you have further questions or concerns after r |
| Quantity | 313 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.