Synthes Recalls 16mm Chisel Blades Due to Incorrect Size Marking
Synthes (USA) Products LLC is recalling 100 units of 16mm Chisel Blades that were incorrectly etched as 16mm when they are actually 10mm.
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, but the source text describes a labeling/etching error without reporting any specific injuries, hospitalizations, or deaths. This aligns with the rubric for moderate severity involving labeling errors or low-risk contamination where harm has not been reported.
Plain-English summary
Synthes (USA) Products LLC is recalling 100 units of 16mm Chisel Blades. These orthopedic manual surgical instruments are used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set.
The recall was initiated because it was discovered that a 10mm Chisel Blade was etched as a 16mm Chisel Blade. This labeling error could lead to the use of the wrong instrument size during surgery. The affected units have Part Number 399.56 and Lot Number T106341.
The recalled products were distributed in the United States to the states of New Jersey, Virginia, Ohio, Indiana, Michigan, Florida, Wisconsin, California, Tennessee, Maryland, North Carolina, Washington, Utah, Idaho, Missouri, Nevada, and Kansas. Healthcare facilities and consumers should stop using these specific chisel blades and contact Synthes (USA) Products LLC for instructions on return or replacement.
The recalled product
- Product
- 16mm Chisel Blade; used in the LCP Anterior Ankle Arthodesis Plate System and the Hip Preservation Surgery Set. Orthopedic manual surgical instrument.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 100
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)
- Part Number 399.56 Lot Numbers T106341
Distribution
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