X Spine Systems Recalls Fortex Pedicle Screw System Rods
X Spine Systems is recalling 75 Fortex Pedicle Screw System Continuous Radius Rods because they measure 45mm instead of the specified 50mm.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The defect is a dimensional discrepancy (45mm vs 50mm) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
X Spine Systems, Inc. is recalling 75 units of the Fortex Pedicle Screw System Continuous Radius Rod 5.5 - 50mm. The recall is due to a manufacturing defect where the rods measure 45mm in length instead of the specified 50mm.
The affected products were distributed worldwide, including in the United States (Florida, Idaho, Illinois, Kansas, Louisiana, Michigan, Missouri, New Jersey, Ohio, Pennsylvania, and Texas) and in Austria, Germany, and Italy. The specific model number is N60001068, lot number 2943-01, and various serial numbers are listed in the recall documentation.
Healthcare providers and patients should check their inventory or medical records for these specific serial numbers. If the product is found, it should be removed from use and returned to X Spine Systems, Inc. according to the company's instructions.
The recalled product
- Product
- Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
- Manufacturer
- X Spine Systems Inc
- Hazard
- Affected units
- 75
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 (20)
- Model #: N60001068
- Lot #: 2943-01
- Serial #s: 46118
- 46581
- 47296
- 47588
- 47653
- 48164
- 48201
- 48412
- 49156
- 49585
- 49586
- 49649
- G22
- G45
- G47
- G77
- G83
- G87X
Distribution
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