Z-1437-2021Class II

Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter...

Name: Z-1437-2021 Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter...
Creator: Stryker Spine
Published: 2021-03-11
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2021-03-11 / Terminated / root cause: design

FDA source

Stryker Spine began a recall of Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar. Catalogs:TL Inserter (580220100), TL Draw Rod (580220101), Tube Set/Syringe... on 2021-03-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1437-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-11
Posted: 2021-04-20
Terminated: 2023-01-05
Recalling firm: Howmedica Osteonics Corp
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).
Product code: MAX Intervertebral Fusion Device With Bone Graft, Lumbar
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.
Root cause tag: design
FDA 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 in commerce: 169 sets
Distribution: US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
Product codes and lots: (UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1437-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1437-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-28	2021-04-20

Product code MAX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)