Device recall: PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code: Z340H For use in soft tissue approximat

FDA enforcement event 91192 · Class II · initiated 16 Nov 2022 · status Ongoing

DeviceVoluntary: Firm initiated1 product recordSomerville, NJ

FDA enforcement event 91192 is a device recall by Ethicon, Inc. of Somerville, NJ, initiated 16 Nov 2022 and classified Class II, with 1 product record.

FDA defines Class II as 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. 88% of the 839 device enforcement events initiated in 2022 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Ethicon, Inc. has 36 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Ethicon, Inc., Somerville, NJ.

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"

Distribution

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

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0480-2023	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	7,560 eaches	Class II	Ongoing	21 Dec 2022

Context

88%of 2022 device events are Class II839 events that year

1product record in this eventfirm median: 1

36events on this register for the firm

Other enforcement events for Ethicon, Inc.

Initiated	Product (first record)	Type	Class	Records
8 Oct 2024	MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indicated for use in general soft tissue approximat	Device	Class II	1
25 Sep 2024	Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number J358H	Device	Class II	1
10 May 2024	VICRYL (polyglactin 910) Suture - Indicated for use in general soft tissue approximation and/or ligation, including use	Device	Class II	6
23 Apr 2024	SURGIFOAM" Absorbable Gelatin Powder Kit, Product Code 1979.	Device	Class II	1
8 Mar 2024	STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12I	Device	Class II	1
31 Mar 2023	PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in	Device	Class II	1
20 Sep 2022	STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of	Device	Class II	1
8 Aug 2022	PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles	Device	Class II	1
24 Mar 2022	STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A P	Device	Class II	1
4 Jan 2021	Ethicon Dermabond Advanced Topical Skin Adhesive-topical skin adhesive to hold closed easily approximated skin edges of	Device	Class II	1

All 36 events for Ethicon, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "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"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "International (OUS) only: Canada, Japan, Australia and New Zealand"

Is the recall still ongoing?

FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.