Alphatec Spine Recalls Polyaxial Screw Assemblies Due to Incorrect Length Marking
Alphatec Spine is recalling 11 units of the TI Standard Polyaxial Screw Assembly because they were laser marked with the incorrect length of 45 MM.
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 and involves a labeling error (incorrect length marking) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Alphatec Spine, Inc. is recalling 11 units of the TI Standard Polyaxial Screw Assembly, Part # 62065-55, Lot # 634745. The product is a posterior spinal fixation device intended to aid in the surgical correction of various spinal deformities and pathologies in the thoraco-lumbo-sacral portion of the spine.
The recall was initiated because Alphatec Spine confirmed that the affected screw assemblies were laser marked with the incorrect length of 45 MM. The actual product dimensions are 6.5MM x 55MM. The agency classifies this recall as Class II.
The affected units were distributed nationwide, including in Tennessee, Wisconsin, and Florida. No specific instructions for consumers or healthcare providers are provided in the source text.
The recalled product
- Product
- TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subsequent Product Codes: MNH, MNI. The Zodiac Polyaxial Pedicle Screw System is intended for use as a posterior spinal fixation device to aid in the surgical correction of various spinal deformities and
- Manufacturer
- Alphatec Spine, Inc.
- Hazard
- Affected units
- 11
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 (1)
- Lot # 634745
Distribution
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