Tritanium X TL Instruments - intervertebral fusion recall
Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube…
Why was Tritanium X TL Instruments - intervertebral fusion recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
(UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
- Product
- Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube…
- Recalling firm
- Stryker Spine
- Quantity
- 169 sets
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
- Recall date
- April 28, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)