CLASS II ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report

Pds II (polydioxanone) Suture- Violet Monofilament 0 S/A recalled

Ethicon is recalling Pds II (polydioxanone) Suture- Violet Monofilament 0 S/A Ct-1 Product, distributed nationwide in the US. The recall was initiated on 16 Nov 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027

Quantity recalled7,560 eaches

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0480-2023
FDA event ID: 91192
Recalling firm: Ethicon, Somerville, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 16 Nov 2022
FDA classified: 14 Dec 2022
Reported: 21 Dec 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

16 Nov 2022	Recall initiated by company
14 Dec 2022	Classified by FDA	+28 days
21 Dec 2022	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

International (OUS) only: Canada, Japan, Australia and New Zealand

Nationwide

Questions about this recall

Is Pds II (polydioxanone) Suture- Violet Monofilament 0 S/A Ct-1 Product recalled?

Yes. Ethicon recalled Pds II (polydioxanone) Suture- Violet Monofilament 0 S/A Ct-1 Product on 16 Nov 2022. The recall is Class II and its status is Ongoing. Recall number Z-0480-2023.

Why was it recalled?

knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rather than premature post-operative breakage

Which lots are affected?

UDI-DI: 10705031060623 (individual unit); 30705031060634 (sales unit box) Lot: SCMSHK Exp. Date: February 28, 2027

Where was it sold?

International (OUS) only: Canada, Japan, Australia and New Zealand

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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1 Oct 2025Device	CLASS II	Stratafix Spiral PDS Plus Bidirectional Knotless Tissue recalled	Ethicon	Other	Nationwide
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