Ethicon, Inc.: Medical Device Recall in 2019 - (Recall #: Z-0047-2020)

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 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture

Product Classification:

Class II

Date Initiated: August 13, 2019
Date Posted: October 16, 2019
Recall Number: Z-0047-2020
Event ID: 83715
Reason for Recall:

The product does not meet certain internal strength testing specifications.

Status: Terminated
Product Quantity: 416 each
Code Information:

Lot # LPH946 GTIN: 10705031235823

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