PDS Plus Antibacterial Sutures Recalled for Tensile Strength Defect
Ethicon is recalling PDS Plus Antibacterial sutures from specific lots that failed internal tensile strength testing. The defective sutures could fail during or after surgery, creating a risk of serious patient harm.
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: This is a risk-of-harm product (surgical sutures with tensile strength defect) where injury has not been reported. The FDA Class II designation reflects the device's significance, but the absence of reported adverse events and identification through internal testing rather than field failures caps the severity at High per the rubric.
Plain-English summary
Ethicon, LLC is recalling PDS Plus Antibacterial (polydioxanone) sutures because internal testing confirmed that some units from affected lots did not meet the required tensile strength specifications.
Tensile strength is critical for surgical sutures, as it determines the suture's ability to maintain wound closure under physiological stress. Sutures that fail to meet strength requirements could rupture during or after surgery, potentially leading to wound dehiscence, infection, or other serious complications.
The recall affects 868,363 total units distributed nationwide and globally. Healthcare facilities that have received affected lots should review the recalled product numbers and lot numbers and quarantine stock immediately.
No injuries or adverse events have been reported to date. Patients with concerns about sutures used in previous surgeries should contact their healthcare provider. Healthcare providers should identify and remove affected sutures from inventory and consider whether patients who received affected sutures during prior procedures require clinical follow-up.
The recalled product
- Product
- PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP259H50, PDP416H50, PDP441H50, PDP442H50, PDP489G50, PDP489H40, PDP497G51, PDP497H16, PDP497H40, PDP498H40, PDP502V05, PDP507V05, PDP510V05, PDP515V05, PDP662H50, PDP663H50, PDP684H40, PDP9615H40, PDP9625
- Manufacturer
- ETHICON, LLC
- Hazard
- tensile-strength-defect
- device-failure
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 (20)
- UDI-DI: 10705031122574
- 10705031047952
- 10705031048232
- 10705031048294
- 10705031048300
- 10705031048393
- 10705031123786
- 10705031048447
- 10705031123854
- 10705031123861
- 10705031203969
- 10705031203983
- 10705031204010
- 10705031204034
- 10705031048546
- 10705031048553
- 10705031124059
- 10705031124677
- 10705031124691
- 10705031124707
Distribution
Distributed nationwide across the United States.
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