Ethicon Recalls STRATAFIX Spiral Sutures Due to Strength Testing Failures
Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 sutures because they do not meet internal strength testing specifications.
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 does not report any illnesses, injuries, or hospitalizations, indicating a theoretical risk of harm rather than a confirmed adverse event.
Plain-English summary
Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle sutures, product code SXPP1B401. The recall is being conducted because the product does not meet certain internal strength testing specifications.
The affected lot number is MMH401, with GTIN 10705031236042. The products were distributed to healthcare facilities in the United States and internationally, including Australia, Hong Kong, India, Japan, Korea, Singapore, and Thailand.
Healthcare providers should stop using the affected sutures and contact Ethicon, Inc. for further instructions on the recall.
The recalled product
- Product
- STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 852
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 (1)
- Lot # MMH401 GTIN: 10705031236042
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ethicon, Inc. 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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