Ethicon Recalls STRATAFIX Spiral PDS Plus Violet Sutures
Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures because the product does 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. The hazard is a failure to meet internal strength specifications, which fits the criteria for a moderate severity recall involving a theoretical or unreported risk of harm.
Plain-English summary
Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures, product code SXPP1B430. The recall is limited to Lot # LPH946 with GTIN 10705031235823.
The recall was initiated because the product does not meet certain internal strength testing specifications. The affected units were distributed to facilities in the United States and internationally, including Australia, Hong Kong, India, Japan, Korea, Singapore, and Thailand.
Healthcare providers and facilities should stop using the affected sutures and contact Ethicon, Inc. for instructions on return or replacement. Consumers should not use these products if they have them in their possession.
The recalled product
- Product
- STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 416
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 # LPH946 GTIN: 10705031235823
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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