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U.S. Department of Health and Human Services

Class 2 Device Recall Trilliant Surgical Ltd Twist Sublatar Implant System

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 Class 2 Device Recall Trilliant Surgical Ltd Twist Sublatar Implant Systemsee related information
Date Initiated by FirmJuly 19, 2018
Create DateMarch 30, 2020
Recall Status1 Terminated 3
Recall NumberZ-1607-2020
Recall Event ID 84977
510(K)NumberK103183 
Product Classification Screw, fixation, bone - Product Code HWC
ProductInstructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical Ltd Twist Sublatar Implant System, Model 112-00-001. The firm name on the label is Trilliant Surgical, Ltd, Houston, TX.
Code Information IFUs previous to Document #900-01-003 Rev. M and Cleaning and Sterilization Protocols previous to Document #900-06-015 Rev. C.
Recalling Firm/
Manufacturer		 Trilliant Surgical, LLC
727 N Shepherd Dr Ste 100
Houston TX 77007-1320
For Additional Information ContactMs. Meagan Olson
800-495-2919 Ext. 1007
Manufacturer Reason
for Recall		Instructions for Use (IFU) and Surgical Cleaning and Sterilization Protocols updated with revised dry time parameters. This recall of IFU occurred in 2018.
FDA Determined
Cause 2		Labeling Change Control
ActionThe recalling firm issued letters as of 7/19/2018 via FedEx.
Quantity in Commerce4 systems total for both Twist Sublatar and Disco Sublatar
DistributionDistribution to US states: AZ, CA, CT, FL, GA, IA, IL, IN, LA, MD, MI, MN, MO, MT, ND, NE, NH, NJ, OH, OK, PA, SD, TN, TX, VA, WA, WI, WY, and PR. There was government distribution and no military distribution. Foreign distribution to Australia, India, Italy, Panama, and Turkey.
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 = HWC
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