Stryker Recalls Tritanium X TL Spinal Instruments Due to Failure Risk
Stryker Spine is recalling 169 sets of Tritanium X TL instruments because non-conforming components could lead to device failure during surgery.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of device failure during a surgical procedure, which aligns with the rubric criteria for Severe severity involving significant injury risk or structural defects.
Plain-English summary
Stryker Spine is recalling 169 sets of Tritanium X TL instruments, which are intervertebral fusion devices with bone graft for lumbar use. The recall involves specific components including the TL Inserter, TL Draw Rod, Tube Set/Syringe Adapter Assembly, and Syringe Plunger.
The firm identified non-conformances in these instruments that could lead to device failure during a procedure. The affected products were distributed nationwide in the United States, specifically in the states of Arizona, California, Colorado, Georgia, Kentucky, Massachusetts, Montana, North Carolina, Nebraska, New Jersey, New York, Ohio, Pennsylvania, and Wyoming.
Healthcare providers and patients should stop using the affected instruments and contact Stryker Spine for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- 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).
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 169
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- (UDI): 07613327366310
- 07613327366839680220102
- 07613327366884
- 07613327366457
Distribution
Related recalls
Same manufacturer · Stryker Spine
See all →- HighStryker Spine Monterey AL Implant Inserter Recall Due to Potential Gold Button Separation
FDA (Devices) · 2025-04-09
- HighStryker Spine Monterey AL Implant Inserter Gold Unlock Button Separation Recall
FDA (Devices) · 2025-04-09
- HighStryker Monterey AL Implant Inserter Gold Button Detachment Risk
FDA (Devices) · 2025-04-09
- HighStryker Spine Monterey AL Implant Inserter Recalled for Potential Unlock Button Separation
FDA (Devices) · 2025-04-09
- ModerateAVS Anchor-C Cervical Cage Instructions for Use Labeling Correction
FDA (Devices) · 2024-10-02
Same hazard · device failure
See all →- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- SevereMedline Neonatal Heated Wire Breathing Circuits Recalled for Thermal Damage Risk
FDA (Devices) · 2026-09-02
- HighBoston Scientific Recalls OverStitch Suture Cinch Devices for Deployment Failure
FDA (Devices) · 2026-08-26
- HighCOAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
FDA (Devices) · 2026-08-12
- HighCOAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
FDA (Devices) · 2026-08-12
Similar recalls
- SevereStryker Triathlon Patella Inserter Recalled for Instrument Fracture Risk
FDA (Devices) · 2014-07-09
- HighStryker Spine Recalls Reliance AL Implant Blocker Due to Prong Breakage
FDA (Devices) · 2012-08-15
- HighStryker Recalls Static Inserter Assemblies Due to Weld Fracture Complaints
FDA (Devices) · 2014-03-05
- HighHowmedica Recalls Tritanium TL Steerable Inserter Due to Locking Mechanism Failure
FDA (Devices) · 2018-10-31
- SevereStryker Recalls Aria Inserter Devices Due to Product Fracturing
FDA (Devices) · 2014-09-17
- HighStryker Spine Recalls Specialty Audible Torque Wrench Due to Fracture
FDA (Devices) · 2014-12-24