Recall Z-1437-2021 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Stryker Spine
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).
| Date | Mar 11, 2021 |
| Status | Terminated |
| 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. |
| Root cause | 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 | 169 sets |
| Distribution | US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.