Recall Z-2321-2017 ยท OWI Bone Fixation Cerclage, Sublaminar
OrthoPediatrics Corp
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.
| Date | Apr 24, 2017 |
| Status | Terminated |
| Reason | Over-tensioning of the band resulting in damage to the band causing it to rupture |
| 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: mfox@orthopediatrics.com. |
| Quantity | 82 |
| Distribution | Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161267 | Response BandLoc Spinal Fixation OrthoPediatrics Corp., Aug 11, 2016 |