Orthopedics 6 — Class II medical device recall Z-2742-2020
Ongoing recall by OrthoPediatrics Corp, reported 2020-08-05, distributed nationwide. Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised st
| Recall number | Z-2742-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2020-07-06 |
| Classified | 2020-07-30 |
| Reported by FDA | 2020-08-05 |
| Distributed | Nationwide (US) |
| Quantity | 73 units |
| Reason classes | potency, device malfunction |
| Lot numbers | 108332-A |
| Model numbers | 00-1300-6053 |
Product
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease Model Number: 00-1300-6053
Reason for recall
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
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-2742-2020. 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.