Ethicon PDS II Surgical Sutures Recalled for Deficient Knot Strength
Ethicon recalls PDS II violet monofilament sutures due to significantly reduced knot tensile strength, posing risk of intra-operative breakage in surgical procedures. The affected lot was distributed internationally to Canada, Japan, Australia, and New Zealand.
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 Class II medical device used in high-risk surgical applications (pediatric cardiovascular surgery) where deficient knot strength poses significant injury risk. However, no illnesses or injuries have been reported in the source material, and the hazard is theoretical. Per the rubric, theoretical hazards without reported injury score at most 3 (High).
Plain-English summary
Ethicon, Inc. is recalling PDS II polydioxanone sutures (violet monofilament, 27 inches, 0 gauge, single-armed with CT-1 needle) used in soft tissue approximation, including pediatric cardiovascular and ophthalmic surgery.
Testing revealed that knot tensile strengths in the affected lot were significantly below the required minimum specification. This deficiency creates a risk of suture breakage prior to use or during surgery, rather than after the procedure is complete.
The affected lot (SCMSHK, expiration date February 28, 2027, UDI-DI 10705031060623) comprised 7,560 units distributed internationally to Canada, Japan, Australia, and New Zealand. Healthcare facilities in these countries that received this lot should identify and quarantine affected products.
Surgeons and healthcare providers who have used or possess sutures from this lot should consult Ethicon directly for guidance on potential patient follow-up or product replacement.
The recalled product
- Product
- PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery
- Manufacturer
- Ethicon, Inc.
- Category
- Medical Device — Surgical Suture
- Hazard
- Affected units
- 7,560
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: 10705031060623 (individual unit)
- 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28
- 2027
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
- HighVICRYL Sutures recalled due to packaging defect compromising 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
Similar recalls
- HighEthicon PDS II Surgical Sutures Recalled for Incorrect Material
FDA (Devices) · 2022-09-28
- HighPDS II Polydioxanone Sutures Recalled Due to Compromised Sterility
FDA (Devices) · 2024-06-26
- HighPDS II Surgical Sutures Recalled for Tensile Strength Defect
FDA (Devices) · 2023-09-27
- ModerateEthicon Recalls PDS II Sutures for Tensile Strength Deficiency
FDA (Devices) · 2018-08-01
- ModerateEthicon Recalls VICRYL and PDS Sutures Due to Labeling Mismatches
FDA (Devices) · 2019-04-24
- HighPDS Plus Antibacterial Suture Potential Breakage During Intraoperative Use
FDA (Devices) · 2023-05-17