Recall Z-0048-2020— Ethicon, Inc.

Name: FDA recall Z-0048-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-13

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2019-08-13, terminated 2021-02-11. It names one FDA 510(k) clearance: K182873. Product: STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture. Reason: The product does not meet certain internal strength testing specifications..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-08-13
Terminated: 2021-02-11
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K182873 — STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control DevicesETHICON, Inc.·cleared 2019-01-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

The product does not meet certain internal strength testing specifications.

Data sourced from openFDA. This site is unofficial and independent of the FDA.