Z-2321-2017Class II

Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow...

Name: Z-2321-2017 Response BandLoc 5.5/6.0 Tensioner Instrument The Tensioner Instrument (01-1102-1000) is utilized to allow...
Creator: OrthoPediatrics Corp
Published: 2017-04-24
License: https://open.fda.gov/license/

Orthopediatrics Corp / initiated 2017-04-24 / Terminated / root cause: design

FDA source

OrthoPediatrics Corp began a 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 recommended tension to the... on 2017-04-24. FDA classified it as Class II and gives the reason as "Over-tensioning of the band resulting in damage to the band causing it to rupture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2321-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-24
Posted: 2017-06-09
Terminated: 2017-09-18
Recalling firm: Orthopediatrics Corp
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.
Product code: OWI Bone Fixation Cerclage, Sublaminar
Reason for recall: Over-tensioning of the band resulting in damage to the band causing it to rupture
Root cause tag: design
FDA root cause: Device Design
Action: The firm, OrthoPediatrics Corp., contacted each distributor/consignee via phone on 4/24/2017, regarding the recall. The phone call informed Consignees of issue and actions to be taken. The consignees were instructed to return of devices in their control were issued; cease further distribution of the product and quarantine it. The firm state that product will be distributed after Rework to new revision. If you have any questions, contact V.P. Regulatory Affairs, at (574) 268-6379 or email: [email protected].
Quantity in commerce: 82
Distribution: Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Product codes and lots: All lots Product Number: 01-1102-1000

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2321-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2321-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-08

Product code OWI

K161267Class IIResponse BandLoc Spinal FixationOrthoPediatrics Corp. / cleared 2016-08-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)