Synthes 0.76 mm Drill Bit Recalled for Incorrect Labeling
Synthes (USA) Products LLC is recalling 84 units of 0.76 mm Drill Bits that may be incorrectly labeled and actually contain 1.1 mm drill bits.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 larger drill bit is mislabeled as a smaller one. This fits the rubric for moderate severity involving minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Synthes (USA) Products LLC is recalling 84 units of Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile. The recall is due to a labeling error where the package may be incorrectly labeled as containing a 0.76 mm drill bit, but in fact contains a 1.1 mm diameter drill bit.
The affected product is identified by Model/Catalog # 316.15 and Lot/Serial Number U172728. The units were distributed nationwide. The source text does not specify specific healthcare facilities or patient populations affected.
Healthcare providers should check their inventory for the specific model and lot number listed above. If the product is found, it should be removed from use and returned to the recalling firm according to their instructions. The source text does not provide specific contact information for the recall.
The recalled product
- Product
- Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 84
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)
- Model/Catalog # 316.15 Lot/Serial Number U172728
Distribution
Distributed nationwide across the United States.
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