Ethicon, Inc.: Device Recall

Recall Details

Recall Number

Z-2146-2024

Classification

Class II

Product Type

Device

Recalling Firm

Ethicon, Inc.

Status

Ongoing

Date Initiated

05/10/2024

Location

Raritan, NJ, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

56952 units

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 .

Product Description

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

Distribution Pattern

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.

Other Recalls by Ethicon, Inc.

• Class II: Risk 10/08/2024
  Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/size and suture length.
• Class II: Risk 09/25/2024
  Complaints were received regarding needle pull-off and suture degradation. Analysis on returned product from this lot confirmed that some sutures were visually degraded in the package.
• Class II: Risk 05/10/2024
  Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
• Class II: Risk 05/10/2024
  Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
• Class II: Risk 05/10/2024
  Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .

View all recalls by Ethicon, Inc. →