Ethicon, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1053-2022)

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 sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

Product Classification:

Class II

Date Initiated: March 24, 2022

Date Posted: May 18, 2022

Recall Number: Z-1053-2022

Event ID: 90016

Reason for Recall:

Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

Status: Ongoing

Product Quantity: 2808 (all OUS)

Code Information:

Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049

Distribution Pattern:

International distribution in the country of China.

Voluntary or Mandated:

Voluntary: Firm initiated