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U.S. Department of Health and Human Services

Class 2 Device Recall Tritanium X TL Instruments

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  Class 2 Device Recall Tritanium X TL Instruments see related information
Date Initiated by Firm March 11, 2021
Create Date April 20, 2021
Recall Status1 Terminated 3 on January 05, 2023
Recall Number Z-1437-2021
Recall Event ID 87580
Product Classification Intervertebral fusion device with bone graft, lumbar - Product Code MAX
Product Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe Adapter Assembly (680220100), Syringe Plunger (680220102).
Code Information (UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
Recalling Firm/
Manufacturer		 Stryker Spine
2 Pearl Ct
Allendale NJ 07401-1611
For Additional Information Contact Margarita Karan
201-749-8389
Manufacturer Reason
for Recall		 Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found non-conformances with the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger that could lead to device failure during a procedure.
FDA Determined
Cause 2		 Device Design
Action On 03/17/2021, Stryker issued an Urgent Medical Device Recall notice to customers and distributers via letter because the firm identified non-conforming components of the Titanium X TL sets which could lead to device failure in the field.
Quantity in Commerce 169 sets
Distribution US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
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.
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