FDA recall Z-1533-2024

Ethicon, Inc. · Class II · device

Product

STRATAFIX Spiral MONOCRYL Plus Bidirectional Knotless Tissue Control Device: STRATAFIX SPIRAL MONOCRYL PLUS BI UD 12+12IN(30+30CM) USP3-0(M2) D/A PS PRM- Indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product Code: SXMP2B412

Reason for recall

Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility

Distribution

CO GA IA MI NJ NY NY PA SC WI

Key facts

Status
Ongoing
Initiation date
2024-03-08
Report date
2024-04-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raritan, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1533-2024