Date Initiated by Firm |
April 24, 2017 |
Create Date |
June 09, 2017 |
Recall Status1 |
Terminated 3 on September 18, 2017 |
Recall Number |
Z-2321-2017 |
Recall Event ID |
77270 |
510(K)Number |
K161267
|
Product Classification |
Bone fixation cerclage, sublaminar - Product Code OWI
|
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. |
Code Information |
All lots Product Number: 01-1102-1000 |
Recalling Firm/ Manufacturer |
OrthoPediatrics Corp 2850 Frontier Dr Warsaw IN 46582-7001
|
For Additional Information Contact |
Gregory E. Teghtmeyer 574-268-6379
|
Manufacturer Reason for Recall |
Over-tensioning of the band resulting in damage to the band
causing it to rupture
|
FDA Determined Cause 2 |
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 in Commerce |
82 |
Distribution |
Worldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = OWI and Original Applicant = ORTHOPEDIATRICS CORP.
|