AEQUALIS FLEX REVIVE Assembly Screw 0mm — Class II medical device recall Z-2019-2023
Ongoing recall by Tornier, Inc, reported 2023-07-05, distributed nationwide. A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Reviv
| Recall number | Z-2019-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Tornier, Inc, Bloomington, MN, United States |
| Recall initiated | 2023-06-12 |
| Classified | 2023-06-28 |
| Reported by FDA | 2023-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, ES, GB, NL |
| Quantity | 55 units |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00846832069408 |
| Serial numbers | AZ1822082001, AZ1822082002, AZ1822082003, AZ1822082004, AZ1822082005, AZ1822082006, AZ1822082007, AZ1822082008, AZ1822082009, AZ1822082010, AZ1822082011, AZ1822082012, AZ1822082013, AZ1822082014, AZ1822082015, AZ1822082016, AZ1822082017, AZ1822082018, AZ1822082019, AZ1822082020, AZ1822082021, AZ1822082022, AZ1822082023, AZ1822082024, AZ1822082025 and 30 more |
| Model numbers | ARS655101 |
Product
AEQUALIS FLEX REVIVE Assembly Screw 0mm, Model Number ARS655101
Reason for recall
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short (ARS655118) & vice versa.
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-2019-2023. 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.