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Stryker Spine Recall 87580

Description: 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).

Stryker Spine Recall 87580 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1437-2021
Event ID87580
Event DescriptionTritanium 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).
Product TypeDevices
DistributionUS Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
Quantity169 sets
Recall ReasonStryker 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.
Device Classification20210428
Device Code Info(UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
Center Classification Date20210420
Recall Initiation Date20210311
Recalling FirmStryker Spine
Initial Notification Letter
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