Device 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
Z-1136-2019
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 82420
- Status
- Terminated
- Classification
- Class II
- Quantity
- 550,681 eaches (WW) Total
- Official record key
device-enforcement:Z-1136-2019
Official wording
Reason: VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.
Code information: Lot Code: MGM110
Distribution pattern: Worldwide distributions - US Nationwide and countries of AUSTRALIA BELGIUM CANADA CHINA ISRAEL JAPAN PUERTO RICO SINGAPORE
Derived failure modes
-
Unknown
VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales unit carton and foil label.