Ethicon Recalls PDS II Sutures for Tensile Strength Deficiency
Ethicon, Inc. is recalling 72 units of PDS II sutures because they do not meet tensile strength specifications.
What this means for you
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, fitting the criteria for a moderate severity score.
Plain-English summary
Ethicon, Inc. is recalling 72 units of PDS II (Polydioxanone) Suture, specifically the Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle (Product Code: Z511G, GTIN 10705031061347). The affected lot number is MCZ363. The recall is limited to distribution in Japan.
The recall was initiated because the products do not meet a tensile strength specification. This is an FDA Class II recall, indicating that use of, or exposure to, the violation may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Healthcare providers and facilities that have received this product should stop using it and contact Ethicon, Inc. for further instructions on return or disposal.
The recalled product
- Product
- PDS II (Polydioxanoe) Suture Dyed & Undyed-PDSII Undyed 45cm (18") 5-0 Single Armed PS-6 Prime Needle Product Code: Z511G (GTIN 10705031061347)
- Manufacturer
- Ethicon, Inc.
- Affected units
- 72
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 Number: MCZ363
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.
See all 3 products in this recall →Related recalls
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