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