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.
FDA Recall Z-2321-2017 · Posted None
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Recalling FirmOrthoPediatrics Corp
Recall StatusTerminated
Product CodeOWI
Date Initiated2017-04-24
Date Terminated2017-09-18
Product Quantity82
Reason for Recall
Over-tensioning of the band resulting in damage to the band
causing it to rupture
Firm 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].
Root Cause
Device Design
Distribution Pattern
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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