Ethicon, Inc.: Medical Device Recall in 2024 - (Recall #: Z-1533-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412

Product Classification:

Class II

Date Initiated: March 8, 2024

Date Posted: April 24, 2024

Recall Number: Z-1533-2024

Event ID: 94220

Reason for Recall:

Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

Status: Ongoing

Product Quantity: 395 units

Code Information:

UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024

Distribution Pattern:

CO GA IA MI NJ NY NY PA SC WI

Voluntary or Mandated:

Voluntary: Firm initiated