Recall Z-1487-2017 ยท JDR Staple, Fixation, Bone
Crossroads Extremity Systems Llc
MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.
| Date | Mar 20, 2017 (initiated Feb 16, 2017) |
| Status | Terminated |
| Reason | Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm. |
| Root cause | Labeling mix-ups |
| Action | The firm notified their distributors by email on 02/16-17/2017. The distributors were asked to return the unused lot #101866. The firm also contacted the implanting surgeons either by visit or telephone about the potential for an incorrect size of the implant and asked if there were any adverse events. |
| Quantity | 20 units |
| Distribution | Al, FL, IN, Il, NE, TX, NM, CO, AZ |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142727 | CrossCLIP Implant System Orthodiscovery Group, LLC(D.B.A. Crossroads Extremity Systems, Oct 24, 2014 |