Ethicon Recalls Stratafix Spiral Sutures Due to Testing Failures
Ethicon, Inc. is recalling 660 units of Stratafix Spiral PDS Plus Violet sutures because the product did not meet internal 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, but the source text does not report any illnesses, injuries, or hospitalizations, and the defect is described as a failure to meet internal testing specifications rather than a specific high-risk hazard.
Plain-English summary
Ethicon, Inc. is recalling 660 units of 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, model SXPP1B402. The recall was initiated because the product did not meet certain internal testing specifications.
The affected units are identified by Lot Numbers PAH073 and PAH054, with an expiration date of 12/31/2020. The GTIN for the product is 10705031236059. Distribution was international, 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 further instructions regarding the return or disposal of the product.
The recalled product
- Product
- 1 STRATAFIX" Spiral PDS Plus Violet 36" (90cm) CTX Needle, SXPP1B402
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 660
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)
- GTIN: 10705031236059 Lot Numbers: PAH073
- PAH054 Expiration Date: 12/31/2020
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 3 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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