Recall Z-0104-2019 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Valeris Medical, LLC
Valeris Medical Apollo Medial Suture Anchor, Catalog Number MSA-4515, 4.5 x 15mm, each package contains (1) PEEK Screw, (1) #2 ForceBraid Blue, and (1) #2 ForceBraid White, 5 packages per container, Sterile, Rx. The firm name on the label is Valeris Medical, Marietta, GA.
| Date | Jul 16, 2018 |
| Status | Terminated |
| Reason | The product was mislabeled as containing the incorrect type of suture. |
| Root cause | Process control |
| Action | The recalling firm issued a letter dated 7/13/2018 via email on 7/16/2018 to their consignees to inform them the product is mislabeled and contains blue and green sutures rather than blue and white sutures as is indicated on the label. |
| Quantity | 75 units |
| Distribution | Distribution was made to FL, OH, OK, and TX, Foreign distribution was made to the United Kingdom and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS Amendia, Inc., Mar 6, 2014 |