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U.S. Department of Health and Human Services

Class 2 Device Recall Response BandLoc 5.5/6.0 Tensioner Instrument

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 Class 2 Device Recall Response BandLoc 5.5/6.0 Tensioner Instrumentsee related information
Date Initiated by FirmApril 24, 2017
Create DateJune 09, 2017
Recall Status1 Terminated 3 on September 18, 2017
Recall NumberZ-2321-2017
Recall Event ID 77270
510(K)NumberK161267 
Product Classification Bone fixation cerclage, sublaminar - Product Code OWI
ProductResponse 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 ContactGregory 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
ActionThe 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 Commerce82
DistributionWorldwide Distribution-US distribution to: MO, NY, KY, FL, NC and OH; and countries of: AUSTRALIA, FRANCE and SPAIN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = OWI
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