Tritanium X TL Instruments — Class II medical device recall Z-1437-2021
Terminated recall by Stryker Spine, reported 2021-04-28, distributed nationwide. Stryker identified non-conforming instruments that are components of the Tritanium X TL sets. The firm found n
| Recall number | Z-1437-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Spine, Allendale, NJ, United States |
| Recall initiated | 2021-03-11 |
| Classified | 2021-04-20 |
| Reported by FDA | 2021-04-28 |
| Terminated | 2023-01-05 |
| Distributed | Nationwide (US) |
| Quantity | 169 sets |
| UPC / GTIN / UDI-DI | 07613327366310, 07613327366457, 07613327366884 |
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).
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1437-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.