Ethicon Recalls Stratafix Spiral Sutures for Internal Testing Failures
Ethicon, Inc. is recalling 133 units of Stratafix Spiral PDS Plus Violet sutures because they do 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. The source text cites internal testing failures without reporting specific injuries, illnesses, or deaths, which aligns with the Moderate severity criteria for low-risk or precautionary recalls.
Plain-English summary
Ethicon, Inc. is recalling 133 units of 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429. The recall is identified by FDA recall number Z-1336-2020.
The reason for the recall is that the product does not meet certain internal testing specifications. The affected units have the GTIN 10705031235816, Lot Number PAH166, and an expiration date of 12/31/2020.
The product was distributed internationally to Australia, Hong Kong, India, Japan, Korea, Singapore, and Thailand. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- 1 STRATAFIX" Spiral PDS Plus Violet 12" (30 cm) CT-1 Needle, SXPP1B429
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 133
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)
- GTIN: 10705031235816 Lot Number: PAH166 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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