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

Z-1533-2024

March 08, 2024

Class II

Product summary

Firm: Ethicon, Inc.
Event: Event 94220
Status: Ongoing
Classification: Class II
Quantity: 395 units
Official record key: device-enforcement:Z-1533-2024

Official wording

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

Code information: UDI/GTIN: 30705031464289 (box) 10705031464285 (pouch) Lot Number: SHBAEC Exp. Date: June 30, 2024

Distribution pattern: CO GA IA MI NJ NY NY PA SC WI

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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