Synthes Recalls 2.5 mm Guide Rods Due to Peel Pouch Delamination
Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rods because their sterile 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 defect involves packaging integrity (delamination) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 139 units of 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile. The affected products are identified by Catalog ID 355.042S and Lot Numbers H085634 and H094463.
The recall was initiated because the peel pouches for the affected reaming rods and extraction hooks are delaminating. This defect may compromise the sterile integrity of the packaging.
The products were distributed nationwide. Healthcare facilities and consumers should stop using these specific lots and contact the manufacturer for further instructions.
The recalled product
- Product
- 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 139
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 (3)
- Catalog ID 355.042S
- Lot Numbers: H085634
- H094463.
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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