Recall Z-1136-2019— Ethicon, Inc.
Class II · Terminated
Class II FDA medical device recall by Ethicon, Inc., initiated 2019-03-12, terminated 2020-07-17. FDA's recall record names no specific 510(k) clearance for this event. Product: PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable. Reason: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label..
- Recalling firm
- Ethicon, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-12
- Terminated
- 2020-07-17
- Firm location
- Somerville, NJ, United States
Product description
PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intended for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery. PDS II suture is not indicated in adult cardiovascular tissue, microsurgery and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable
Reason for recall
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
Data sourced from openFDA. This site is unofficial and independent of the FDA.