Ethicon, Inc.: Medical Device Recall in 2022 - (Recall #: Z-0150-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12

Product Classification:

Class II

Date Initiated: September 20, 2022

Date Posted: November 9, 2022

Recall Number: Z-0150-2023

Event ID: 90890

Reason for Recall:

Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

Status: Ongoing

Product Quantity: 2,280 eaches

Code Information:

UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026

Distribution Pattern:

International distribution of the country of China.

Voluntary or Mandated:

Voluntary: Firm initiated