Recall Z-1533-2024— Ethicon, Inc.
Class II · Ongoing
Class II FDA medical device recall by Ethicon, Inc., initiated 2024-03-08. It names one FDA 510(k) clearance: K192580. 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: Degraded and unusable upon removal from the foil pouch due to exposed environmental conditions during transit and storage, compromising sterility.
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-08
- Firm location
- Raritan, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.