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.
What this means for you
Illness, injury, or structural failure has been reported. 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
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