FDA Device recall Z-2321-2017
Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommend…
- FDA Device
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow the surgeon to apply a recommend… by Orthopediatrics, citing over-tensioning of the band resulting in damage to the band causing it to rupture.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2321-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-04-24 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Orthopediatrics |
| Distribution | FL, KY, MO, NC, NY, OH |
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
Over-tensioning of the band resulting in damage to the band causing it to rupture
Identifiers
| code_info | All lots Product Number: 01-1102-1000 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2321-2017%22
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