Synthes Extraction Hook Recall Due to Peel Pouch Delamination
Synthes (USA) Products LLC is recalling 114 sterile extraction hooks because their peel pouches are delaminating, potentially compromising sterility.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a packaging defect (delamination) that poses a theoretical risk to sterility, fitting the criteria for a moderate severity score where the risk is present but not yet realized in reported harm.
Plain-English summary
Synthes (USA) Products LLC is recalling 114 units of the Extraction Hook - Sterile for TI Cannulated Nails. The recall is due to a defect in the packaging where the peel pouches are delaminating. This defect may compromise the sterile barrier of the medical device.
The affected products are identified by Catalog ID 355.399S and Lot Number H102610. The recall is classified as Class II by the U.S. Food and Drug Administration. The products were distributed nationwide.
Healthcare providers and facilities should stop using the affected extraction hooks and contact Synthes (USA) Products LLC for further instructions on return or replacement. Patients who have already received treatment with these devices should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Extraction Hook - Sterile for TI Cannulated Nails
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 114
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 (2)
- Catalog ID 355.399S
- Lot Numbers: H102610
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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