Ethicon Surgical Sutures Recalled Due to Silicone Curing Manufacturing Defect
Ethicon Endo Surgery recalls approximately 1,080 surgical sutures due to silicone curing issues identified during manufacturing. The defect may affect suture performance during surgical use.
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: FDA Class II recall of a surgical device with a manufacturing defect affecting the silicone coating. No illnesses or injuries have been reported. Risk-of-harm product where injury has not yet been reported meets the High severity criterion.
Plain-English summary
Ethicon Endo Surgery, LLC is recalling approximately 1,080 PDSII surgical sutures (size USP 6-0, 30 inches in length, lot 104BQC) due to curing issues identified with the silicone during the manufacturing process.
The affected sutures have silicone coating that did not cure properly during manufacturing. This defect has been classified by the FDA as a Class II recall.
The recalled product was distributed worldwide to the United States and to 21 additional countries including Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Germany, India, Israel, Japan, Lithuania, Mexico, Netherlands, New Zealand, Norway, Panama, Singapore, Spain, Taiwan, and Uruguay.
Healthcare providers and facilities that have received this product should cease using the recalled sutures and contact Ethicon Endo Surgery, LLC for instructions on return or replacement.
The recalled product
- Product
- PDSII¿VIO¿30IN(75CM)¿USP6-0(M0.7)¿D/A¿C-1
- Manufacturer
- Ethicon Endo Surgery, LLC
- Affected units
- 1,080
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 (4)
- Product Code: Z127H-50
- GMDN: 16584
- UDI-DI: 10705031060227
- Lot number: 104BQC
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Ethicon Endo Surgery, LLC 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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