Synthes Recalls 2.5 mm Calibrated Reaming Rods Due to Pouch Delamination
Synthes (USA) Products LLC is recalling 260 sterile 2.5 mm TI Calibrated Reaming Rods because their peel pouches are delaminating.
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 the hazard involves a packaging defect (delamination) that poses a theoretical risk to sterility, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Synthes (USA) Products LLC is recalling 260 units of the 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile. The affected products are identified by Catalog ID 359.083S and Lot Numbers H115566, H116597, H116601, and H117049. These items were distributed nationwide.
The recall was initiated because the peel pouches for the affected reaming rods and extraction hooks are delaminating. This defect may compromise the sterile barrier of the packaging.
Healthcare facilities and consumers should stop using these specific products and contact Synthes (USA) Products LLC for further instructions or a replacement.
The recalled product
- Product
- 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 260
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 (5)
- Catalog ID 359.083S
- Lot Numbers: H115566
- H116597
- H116601
- H117049
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Synthes (USA) Products LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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