Ethicon Recalls PDS Plus Antibacterial Sutures for Tensile Strength Defects
Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures because they do not meet tensile strength specifications. The affected products were distributed in Japan.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a structural defect (tensile strength) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling 756 units of PDS Plus Antibacterial Sutures, specifically the PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle (Product Code: PDP493G, GTIN 10705031203945). The recall is being conducted because the products do not meet a tensile strength specification.
The affected units are identified by Lot Number MCZ162. According to the source data, these products were distributed in Japan.
Consumers and healthcare providers should stop using the affected suture units and contact Ethicon, Inc. for further instructions or a replacement.
The recalled product
- Product
- PDS Plus Antibacterial Suture-PDS PLUS Undyed Suture 45cm (18") 5-0 Single Armed P-3 Prime Needle Product Code: PDP493G (GTIN 10705031203945)
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 756
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:MCZ162
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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