Ethicon Recalls PDS Plus Antibacterial Sutures Due to Tensile Strength Defect
Ethicon, Inc. is recalling specific lots of PDS Plus Antibacterial Sutures because they do not meet tensile strength 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 3/5 (High).
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 is classified as FDA Class II, which falls under the 'High' severity category in the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon, Inc. is recalling 4,992 units of PDS Plus Antibacterial (Polydioxanone) Sutures, specifically the PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle (Product Code: PDP507G, GTIN 10705031203983). The recall affects Lot Number MBK743.
The recall was initiated because the products do not meet a tensile strength specification. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The source text indicates a distribution pattern of Japan. Healthcare providers and patients should check their inventory and records for this specific product code and lot number. If the product has been used, patients should consult their healthcare provider regarding any concerns related to the suture's performance.
The recalled product
- Product
- PDS Plus Antibacterial (Polydioxanone) Suture-PDS PLUS Undyed Suture 45cm (18") 4-0 Single Armed PS-4 Prime Needle Product Code: PDP507G (GTIN 10705031203983)
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 4,992
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: MBK743
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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Same hazard · tensile strength defect
See all →- HighPDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect
FDA (Devices) · 2023-09-27
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