FDA-Device2024-04-24Class II
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
Ethicon, Inc.
Hazard
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Sold states
CO GA IA MI NJ NY NY PA SC WI
Affected count
395 units
Manufactured in
1000 Route 202, Raritan, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1533-2024Don't want to check this manually?
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