FDA Enforcement
Class II
Ongoing
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
Recall: Z-1533-2024
·
Reported April 24, 2024
Enforcement
- Recall Number
- Z-1533-2024
- Event ID
- 94220
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ethicon, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 24, 2024
- Initiation Date
- March 8, 2024
- Classification Date
- April 12, 2024
- Address
- 1000 Route 202, Raritan, NJ, 08869-1425, United States
Description
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
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Code Info
UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024
Distribution
CO GA IA MI NJ NY NY PA SC WI
Quantity
395 units