Recall Z-1571-2023— Ethicon, Inc.

Name: FDA recall Z-1571-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-31

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2023-03-31. It names one FDA 510(k) clearance: K061037. Product: PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H. Reason: Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved.

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2023-03-31
Firm location: Raritan, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K061037 — PDS PLUS ANTIBACTERIAL SUTUREETHICON, Inc.·cleared 2006-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME. Intended for use in general soft tissue approximation, including use in pediatric cardiovascular tissue. Product Code: PDP9625H

Reason for recall

Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or ligation may not be achieved

Data sourced from openFDA. This site is unofficial and independent of the FDA.