Synthes 5.0mm Variable Locking Screw Recalled for Incorrect Package Insert
Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws because one package contained the wrong insert.
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 minor labeling error (incorrect package insert) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes, Inc. is recalling 45 units of 5.0mm Variable Locking Screws (part no. 02.231.240, lot no. 823111). The recall is due to a labeling correction where one package contained a GP0006 (Anterior Cervical Vertebrae Plate System) insert instead of the correct GP2848 (4.5mm VA-LCP Curved Condylar Plate System) insert.
The affected devices were distributed nationwide, including in Georgia, California, Texas, Missouri, Ohio, Pennsylvania, Washington, Alabama, Indiana, Arizona, Michigan, Iowa, Tennessee, Kentucky, North Carolina, Virginia, New York, Louisiana, Illinois, Utah, and Kansas. This recall is classified as Class II by the FDA.
Healthcare providers and facilities should check their inventory for the specific part and lot numbers listed above. If the affected device is found, it should be removed from use and returned to Synthes, Inc. according to the company's instructions.
The recalled product
- Product
- Synthes 5.0mm Variable Locking Screw This device is part of the Variable Angle Locking Compression Plate family and this technology included variable angle Combi holes in the plate shaft.The variable angle Combi hole provides the flexibility of axial compression and variable l
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 45
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 (2)
- part no. 02.231.240
- lot no. 823111
Distribution
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