Response BandLoc 5 — Class II medical device recall Z-2321-2017
Terminated recall by OrthoPediatrics Corp, reported 2017-06-14, distributed in FL, KY, MO, NC, NY, OH. Over-tensioning of the band resulting in damage to the band causing it to rupture
| Recall number | Z-2321-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OrthoPediatrics Corp, Warsaw, IN, United States |
| Recall initiated | 2017-04-24 |
| Classified | 2017-06-08 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2017-09-18 |
| Distributed | FL, KY, MO, NC, NY, OH |
| Countries outside the US | AU, ES, FR |
| Quantity | 82 |
Product
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommended tension to the band and hold it in place during spine manipulation and set screw tightening.
Reason for recall
Over-tensioning of the band resulting in damage to the band causing it to rupture
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-2321-2017. 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.