The Recall Desk

FDA (Devices) recall action 83715

Ethicon, Inc. recalled 2 products on 2019-10-16

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-10-16
Critical
0
Units
1,268

Why these products were recalled

The product does not meet certain internal strength testing specifications.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2019-10-16

    Ethicon Recalls STRATAFIX Spiral Sutures Due to Strength Testing Failures

    Ethicon, Inc. is recalling 852 units of STRATAFIX Spiral PDS Plus Violet 27 sutures because they do not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture
    Category
    Distribution
    18 states
  • ModerateFDA (Devices)··2019-10-16

    Ethicon Recalls STRATAFIX Spiral PDS Plus Violet Sutures

    Ethicon, Inc. is recalling 416 units of STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle sutures because the product does not meet internal strength testing specifications.

    Product
    STRATAFIX Spiral PDS Plus Violet 18 (45cm) CT-1 Needle Product code: SXPP1B430 suture
    Category
    Distribution
    18 states