Z-1533-2024 Class II Ongoing
FDA device recall Z-1533-2024 was initiated by Ethicon, Inc. on March 8, 2024 and is designated Class II. Reason for recall: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility The recall status is ongoing. Affected quantity: 395 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 8, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 395 units
Product 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 for Recall
Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility
Distribution Pattern
CO GA IA MI NJ NY NY PA SC WI
Code Information
UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024