Synthes Recalls 3.0 mm Reaming Rods Due to Peel Pouch Delamination
Synthes (USA) Products LLC is recalling 887 sterile 3.0 mm reaming rods because their peel pouches are delaminating.
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 the source text describes a packaging defect (delamination) without reporting any illnesses, injuries, or specific high-risk pathogens, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 887 units of 3.0 mm Reaming Rod/950 mm, Sterile. The recall is due to a defect where the peel pouches for the affected reaming rods and extraction hooks are delaminating.
The affected products are identified by Catalog ID 351.71S and specific lot numbers: H000111, H033314, H067857, H067858, H069074, H069079, H087019, H090015, H090747, H100713, and H123976. These products were distributed nationwide.
Healthcare providers and consumers should stop using the affected products and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- 3.0 mm Reaming Rod/950 mm, Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 887
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 (12)
- Catalog ID 351.71S
- Lot Numbers: H000111
- H033314
- H067857
- H067858
- H069074
- H069079
- H087019
- H090015
- H090747
- H100713
- H123976.
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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