Recall Z-1324-2022 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
DePuy Spine, Inc.
EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD) Part Number: CUI8070S
| Date | May 20, 2022 |
| Status | Open, Classified |
| Reason | Label on the Outer Carton does not match the labels on the Outer Blister package, Inner Blister package and Patient Labels. The only label that may not be correct is on the Outer Carton |
| Root cause | Labeling Change Control |
| Action | DePuy Synthes Spine issued Urgent Medical Device Recall Letter dated 5/18/21 to hospitals, sales consultants and sales managers. Letter states reason for recall, health risk and action to take: 1. Examine your inventory immediately to determine if you have the subject products and quarantine the subject products. DO NOT USE THE SUBJECT PRODUCTS. 2. Contact your DePuy Synthes Spine Sales Consultant to coordinate the return/credits of the subject products. 3. Review, complete, sign, and return the attached Business Response Form (See page 3 of this communication) to OneMD-Field-Actions@its.jnj.c |
| Quantity | 46 units |
| Distribution | Distribution US Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K170503 | EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellula Eit Emerging Implant Technologies GmbH, Jul 11, 2017 |