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.
Recall
- Recall Number
- Z-2321-2017
- Event Number
- 77270
- Firm
- OrthoPediatrics Corp
- FEI Number
- 3006460162
- Product Code
- OWI
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- April 24, 2017
- Terminated
- September 18, 2017
- Address
- 2850 Frontier Dr, Warsaw, IN, 46582-7001
Description
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.
Over-tensioning of the band resulting in damage to the band causing it to rupture
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].
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
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