Ethicon, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0048-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture

Product Classification:

Class II

Date Initiated: August 13, 2019

Date Posted: October 16, 2019

Recall Number: Z-0048-2020

Event ID: 83715

Reason for Recall:

The product does not meet certain internal strength testing specifications.

Status: Terminated

Product Quantity: 852 each

Code Information:

Lot # MMH401 GTIN: 10705031236042

Distribution Pattern:

States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States

Voluntary or Mandated:

Voluntary: Firm initiated