FDA Device recall Z-2742-2020
Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization o…
- FDA Device
- Class II
- ongoing
- Published 2020-08-05
On 2020-08-05 the FDA classified a Class II recall of Orthopedics 6.0MM ROD, COCR, SINGLE HEX, 500MM LENGTH-The RESPONSE" 5.5/6.0 Spine System is intended for immobilization and stabilization o… by Orthopediatrics, citing product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2742-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-07-06 |
| Published | 2020-08-05 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Orthopediatrics |
| Distribution | US |
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
Product may have incorrect laser etched alignment lines, the non-conforming laser etch may have compromised strength, lead to unintended fracture of the device
Identifiers
| code_info | Lot Number: 108332-A UDI: (01)0084113212400(10)108332A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2742-2020%22
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