Valeris Medical Apollo Medial Suture Anchor — Class II medical device recall Z-0104-2019
Terminated recall by Valeris Medical, LLC, reported 2018-10-24, distributed in FL, OH, OK, TX. The product was mislabeled as containing the incorrect type of suture.
| Recall number | Z-0104-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeris Medical, LLC, Marietta, GA, United States |
| Recall initiated | 2018-07-16 |
| Classified | 2018-10-12 |
| Reported by FDA | 2018-10-24 |
| Terminated | 2020-08-04 |
| Distributed | FL, OH, OK, TX |
| Countries outside the US | GB, NZ |
| Quantity | 75 units |
| Reason classes | labeling |
| Lot numbers | 1982 |
| Model numbers | 15MM, 4.5, MSA-4515 |
| Expiration dates | 2019-03-22 |
Product
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.
Reason for recall
The product was mislabeled as containing the incorrect type of suture.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0104-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.