Class II Recall

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

Summary

The FDA issued a Class II for PDS II (polydioxanone) Suture- VIOLET MONOFILAMENT 27IN 0 S/A CT-1 Product Code by Ethicon, Inc.. Reason: knot tensile strengths were observed to be significantly below the minimum knot tensile, will result in breakage prior to use or intra-operatively rat.

Details

Source

Device Recall

External ID

Z-0480-2023

Action Date

2022-12-21

Status

Ongoing

Product Description

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

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

Quantity Affected: 7,560 eaches

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

Type: Voluntary: Firm initiated

Recall Initiated: 2022-11-16

Company

Ethicon, Inc.

Somerville, NJ

Context & Analysis

This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.

This was one of 474 device recalls issued in the same week, part of 403 device-related FDA actions this month.

Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 clearances.

Frequently Asked Questions

What is a Class II recall?

A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.

What should I do if I have this product?

Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ethicon, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.

How often does Ethicon, Inc. have FDA actions?

Ethicon, Inc. has 23 FDA actions in our database, including 15 recalls and 8 device clearances.

Where can I find the official FDA record?

The official record is available on FDA.gov. Search for "Z-0480-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.

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