Ethicon PDS II Surgical Sutures Recalled for Incorrect Material
Ethicon recalls PDS II surgical sutures distributed in Japan due to potential incorrect material composition that could affect treatment outcomes. No injuries have been reported.
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: This is a high-risk-of-harm medical device (surgical sutures directly impact treatment outcomes) with a confirmed potential material composition defect, classified as FDA Class II. No injuries or illnesses have been reported, which prevents elevation to Severe.
Plain-English summary
Ethicon, Inc. is recalling PDS II polydioxanone sutures (4-0 size, violet color, 8x18" length) due to the potential for incorrect material composition in affected units. The recalled lot includes 88 boxes (1056 units) with lot number SAMPAL and UDI-DI 10705031061705.
Incorrect material composition could impact the suture's performance during surgical treatment. No illnesses or injuries have been reported in connection with this recall.
Healthcare facilities and medical professionals who have received affected sutures should stop use and contact Ethicon for replacement or proper disposal.
The recalled product
- Product
- PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles
- Manufacturer
- Ethicon, Inc.
- Hazard
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 (3)
- UDI-DI (GTIN): 10705031061705 (individual unit)
- 30705031061709 (sales unit box) Product Number: Z771D
- Lot No: SAMPAL
Distribution
Distribution scope not specified by the agency.
Related recalls
Same manufacturer · Ethicon, Inc.
See all →- HighEthicon Recalls Monocryl Sutures Due to Component Mix-Up
FDA (Devices) · 2024-11-27
- HighCoated VICRYL Surgical Sutures Recalled for Needle Pull-Off and Degradation
FDA (Devices) · 2024-11-13
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- HighPDS Plus Antibacterial Surgical Sutures Recalled for Compromised Sterility
FDA (Devices) · 2024-06-26
- HighMONOCRYL Surgical Sutures Recalled for Packaging Sterility Defect
FDA (Devices) · 2024-06-26
Same hazard · incorrect material
See all →- ModerateBrainlab Knee Navigation Cutting Block Adapter Base Recalled for Material Error
FDA (Devices) · 2017-01-18
Similar recalls
- ModerateEthicon Recalls PDS II Sutures for Tensile Strength Deficiency
FDA (Devices) · 2018-08-01
- HighPDS II Surgical Sutures Recalled for Tensile Strength Defect
FDA (Devices) · 2023-09-27
- HighEthicon PDS II Surgical Sutures Recalled for Deficient Knot Strength
FDA (Devices) · 2022-12-21
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- ModerateEthicon Recalls VICRYL and PDS Sutures Due to Labeling Mismatches
FDA (Devices) · 2019-04-24
- HighEthicon Recalls PDS Plus Antibacterial Sutures Due to Tensile Strength Defect
FDA (Devices) · 2018-08-01