FDA recall Z-0047-2020

Ethicon, Inc. · Class II · device

Product

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

Reason for recall

The product does not meet certain internal strength testing specifications.

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

Key facts

Status
Terminated
Initiation date
2019-08-13
Report date
2019-10-16
Termination date
2021-02-11
Voluntary/Mandated
Voluntary: Firm initiated
Location
Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2020