PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: October 16, 2019 Initiated: August 13, 2019 #Z-0048-2020

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.

Details

Recalling Firm
Ethicon, Inc.
Units Affected
852 each
Distribution
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
Location
Somerville, NJ

Frequently Asked Questions

What product was recalled?
STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture. Recalled by Ethicon, Inc.. Units affected: 852 each.
Why was this product recalled?
The product does not meet certain internal strength testing specifications.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 16, 2019. Severity: Moderate. Recall number: Z-0048-2020.