Recall Z-1009-2018 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Zimmer Biomet, Inc.
fastener, fixation, nondegradable, soft tissue
| Date | Oct 25, 2017 |
| Status | Terminated |
| Reason | It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device. |
| Root cause | Process control |
| Action | In October of 2017 an URGENT MEDICAL DEVICE RECALL LETTER was issued to customers requesting that any remaining product be quarantined and returned to recalling firm. Questions or concerns can be directed to 574-371-3071. |
| Quantity | 429 units |
| Distribution | TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K143037 | SnapShot Fixation System Biomet Manufacturing Corp, Jan 20, 2015 |