Class II — OrthoPediatrics Corp
| Recalling firm | ORTHOPEDIATRICS, CORP |
|---|---|
| Registered facility | ORTHOPEDIATRICS, CORP (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device |
| 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 |
| Quantity | 73 units |
| Distribution | US Nationwide distribution including in the states of Al, CA, FL, GA, KY, MI, MO, NC, NY, OH, TX. |
| Initiated | 2020-07-06 |
| Classified | 2020-07-30 |
| Recall number | Z-2742-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — OrthoPediatrics Corp (Z-2742-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86027/
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