Z-2146-2024Class II

PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in...

Name: Z-2146-2024 PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in...
Creator: Ethicon, Inc.
Published: 2024-05-10
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2024-05-10 / Open, Classified / root cause: packaging

FDA source

Ethicon, Inc. began a recall of PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and... on 2024-05-10. FDA classified it as Class II and gives the reason as "Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2146-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-05-10
Posted: 2024-06-14
Recalling firm: Ethicon, Inc
Product: PDS II (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric cardiovascular tissue, in microsurgery and in ophthalmic surgery. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. PRODUCT CODE: D6261 Z117H Z149H Z259H Z305H Z320H
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Erhicon issued Urgent: Medical Device Recall (Removal) letter on May 10, 2024 to US Distributors, primary and secondary consignees via UPS second day. Ethicon Johnson & Johnson affiliates in EMEA, LATAM, APAC and Canada will be contacting all their impacted primary and secondary consignees and/or end customers. Letter states reason for recall, health risk and action to take: 1. Determine whether you have inventory of the lots listed in Attachment 1. If so, you may " Option 1: Remove the first package of suture from a complete box, i. Quarantine and return it for credit. You may use the remaining 35 sutures in accordance with the IFU. (See Figure 2 below for location of first package) OR ii. Examine the first package of a complete box prior to use. Quarantine and return this unit if a packaging defect is identified. (See Figure 2 below for location of first package). If no defect is found, the product and remaining 35 sutures in the box may be used accordance with the IFU. OR "Option 2: Quarantine all product in scope and return all inventory for credit. Please maintain a copy of this notice with the quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email to Sedgwick at 800-901-0335 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused sutures with holes in the primary packaging subject to this recall that are in inventory immediately. To receive credit for items returned, customers must return product no
Quantity in commerce: 56952 units
Distribution: Worldwide distribution - US Nationwide including PR and the countries of AR, AU, AU, BE, BR, CA, CA, CL, CN, CO, CR, EC, IL, JP, JP, KW, MX, NZ, PA, PR, PR, SA, SG, UY, ZA.
Product codes and lots: GTIN 10705031026216 10705031060166 10705031060289 10705031060395 10705031060517 PRODUCT CODE PRODUCT LOTS VCP196H UBMDDB VCP417H UAMQML VCP602H UAMQQL UAMSCA VCP603H UAMHTC UAMHZZ UAMEDC VCP662H UBMJSH VCPB259H UAMPKR VCPB946H UAMLJA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2146-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2144-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-14
Z-2145-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-14
Z-2146-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-14
Z-2147-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-14
Z-2148-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-14
Z-2149-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-26	2024-06-14

Product code GAM

K183183Class IIVICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical SutureETHICON, Inc. / cleared 2019-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)