The Recall Desk
HighFDA (Devices)·Z-0480-2023·Announced 2022-12-21

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.

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 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
  • knot-weakness
  • breakage

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.

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