CLASS II Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner recalled

OrthoPediatrics is recalling Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is, distributed in Florida, Kentucky, Missouri, North Carolina, New York, Ohio. The recall was initiated on 24 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots Product Number: 01-1102-1000

Quantity recalled82

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2321-2017
FDA event ID: 77270
Recalling firm: OrthoPediatrics, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 24 Apr 2017
FDA classified: 8 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Telephone
Reason category: Other Reasons
Device type: Spinal Implants

Timeline

24 Apr 2017	Recall initiated by company
8 Jun 2017	Classified by FDA	+45 days
14 Jun 2017	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Over-tensioning of the band resulting in damage to the band causing it to rupture

Product as listed by the FDA

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.

Where it was distributed

Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.

Florida Kentucky Missouri North Carolina New York Ohio

Questions about this recall

Why was it recalled?

Over-tensioning of the band resulting in damage to the band causing it to rupture

Which lots are affected?

All lots Product Number: 01-1102-1000

Where was it sold?

Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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