The Recall Desk
HighFDA (Devices)·Z-1773-2022·Announced 2022-09-28

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.

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 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.
Category
Medical Device — Surgical Sutures
Hazard
  • incorrect-material

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.

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