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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1437-2021 |
| Event ID | 87580 |
| Event 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). |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY. |
| Quantity | 169 sets |
| Recall Reason | 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. |
| Device Classification | 20210428 |
| Device Code Info | (UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457 |
| Center Classification Date | 20210420 |
| Recall Initiation Date | 20210311 |
| Recalling Firm | Stryker Spine |
| Initial Notification | Letter |
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