CLASS II Device recall · Reported 28 Apr 2021 · FDA Enforcement Report
Tritanium X TL Instruments - intervertebral fusion device recalled
Stryker Spine is recalling Tritanium X TL Instruments - intervertebral fusion device with bone graft, lumbar, distributed nationwide in the US. The recall was initiated on 11 Mar 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1437-2021
- FDA event ID
- 87580
- Recalling firm
- Stryker Spine, Allendale, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2021
- FDA classified
- 20 Apr 2021
- Reported
- 28 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Spinal Implants
Timeline
| 11 Mar 2021 | Recall initiated by company | |
| 20 Apr 2021 | Classified by FDA | +40 days |
| 28 Apr 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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).
Where it was distributed
US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
Nationwide ArizonaCaliforniaColoradoGeorgiaKentuckyMassachusettsMontanaNorth CarolinaNebraskaNew JerseyNew YorkOhioPennsylvaniaWyoming
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
(UDI): 07613327366310, 07613327366839680220102, 07613327366884, 07613327366457
Where was it sold?
US Nationwide distribution in the states of AZ, CA, CO, GA, KY, MA, MT, NC, NE, NJ, NY, OH, PA, WY.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Stryker Spine
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|---|---|---|---|---|---|
| Device | CLASS II | Monterey AL Implant Inserter recalled by Stryker Spine | Stryker Spine | Other | 13 states |
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|---|---|---|---|---|---|
| Device | CLASS II | Extended Polyaxial Head, Attached Gimbal recalled | Seaspine Orthopedics | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Anterior Spine Pack recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |