Recall Z-0546-2020 · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
SPINEART SA
Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures
| Date | Nov 22, 2019 (initiated Feb 5, 2019) |
| Status | Terminated |
| Reason | Inner blister pack label is incorrect and does not match the correct external box label. |
| Root cause | Employee error |
| Action | On 02/05/2019, the firm sent an "URGENT: MEDICAL DEVICE RECALL FSCA-04-2019" notification letter via email informing its one U.S. Distributor of the issue of incorrect inner blister pack labeling for Lot Number 4-2899. The customer was instructed to please carefully follow instructions detailed below: 1. Immediately review their inventory and quarantine concerned products if any. 2. For customer who may have further distributed this product to please identify concerned customers and notify them at once of this product recall by using the URGENT: MEDICAL DEVICE RECALL" document. 3. Collect an |
| Quantity | 14 pieces distribtued to 1 US Distributor |
| Distribution | US: CA OUS: Unknowns |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153621 | Juliet® Ti Spineart, Jul 15, 2016 |