Synthes 2.5 mm Reaming Rods Recalled for Delaminating Peel Pouches
Synthes (USA) Products LLC is recalling 2,157 sterile 2.5 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 defect involves packaging integrity (delaminating pouches) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 2,157 units of 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile. The recall is due to delaminating peel pouches associated with the affected reaming rods and extraction hooks.
The affected products were distributed nationwide. The specific catalog ID is 351.709S, and the recall covers multiple lot numbers including 9913251, 9913252, and H105530.
Healthcare facilities should stop using the affected products and contact Synthes (USA) Products LLC for further instructions regarding the recall.
The recalled product
- Product
- 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 2,157
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 (20)
- Catalog ID 351.709S
- Lot Numbers: 9913251
- 9913252
- 9913254
- 9913256
- 9913259
- 9913260
- 9950460
- 9950461
- 9950462
- 9950463
- 9950464
- 9963747
- 9963748
- 9963749
- 9963751
- 9963752
- 9963753
- 9963755
- 9963756
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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