Synthes 3.0 mm Guide Rods Recalled for Delaminating Peel Pouches
Synthes (USA) Products LLC is recalling 319 sterile 3.0 mm Guide 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 hazard involves packaging delamination without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes (USA) Products LLC is recalling 319 units of the 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile. The affected products are identified by Catalog ID 355.041S and Lot Numbers H085635, H087271, H094462, H111419, and H136756.
The recall was initiated because the peel pouches for the affected reaming rods and extraction hooks are delaminating. This defect compromises the packaging integrity of the sterile medical devices.
The products were distributed nationwide. Healthcare facilities and consumers should stop using the affected units and contact the recalling firm for further instructions.
The recalled product
- Product
- 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 319
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 (6)
- Catalog ID 355.041S
- Lot Numbers: H085635
- H087271
- H094462
- H111419
- H136756
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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