UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw The… — Class II medical device recall Z-0622-2016
Terminated recall by OrthoPediatrics Corp, reported 2016-01-20, distributed in AL, AZ, CA, DE, FL, GA, HI, KY…. Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, th
| Recall number | Z-0622-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2015-11-10 |
| Classified | 2016-01-08 |
| Reported by FDA | 2016-01-20 |
| Terminated | 2016-05-23 |
| Distributed | AL, AZ, CA, DE, FL, GA, HI, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, TN, TX |
| Quantity | 102 |
Product
UniAxial Pedicle Screw & UniAxial Reduction Pedicle Screw 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 (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudarthrosis, and/or failed previous fusion.
Reason for recall
Response Spine UniAxial Pedicle & UniAxial Reduction Pedicle Screws may have been manufactured incorrectly, thus preventing the driver from fully engaging into the hexagonal drive feature of the screw.
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-0622-2016. 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.