Biomet Recalls 3.5mm Locking Cortical Screws Due to Labeling Error
Biomet is recalling 52 locking cortical screws because a 3.5mmx28mm screw was incorrectly labeled as a 3.5mmx38mm screw.
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 where a shorter screw is mislabeled as a longer one. This fits the rubric for moderate severity, representing a labeling error without reported injuries or fatalities.
Plain-English summary
Biomet, Inc. is recalling 52 units of the 3.5mmx38mm Locking Cortical Screw (Catalog Number 816135038, Lot Number RM244D). The recall was initiated after an investigation identified that a 3.5mmx28mm Cortical Locking Screw was incorrectly labeled as a 3.5mmx38mm Cortical Locking Screw.
The affected devices were distributed in the United States, including the states of Arizona, California, Georgia, Illinois, Kentucky, Michigan, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, South Dakota, Texas, Utah, and Virginia.
Healthcare providers and patients should contact Biomet, Inc. for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Locking Cortical Screw 3.5mmX38mm REF 8161-35-038
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 52
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)
- Catalog Number: 816135038 (8161-35-038) Lot Number Identification: RM244D
Distribution
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