Devices

Device Recall PDS II (polydioxanone) Suture

Model / Serial
Lot # Expiration Date APM091 2013-07-31 12:00AM APM861 2013-07-31 12:00AM APZ105 2013-07-31 12:00AM AMK590 2013-07-31 12:00AM APZ721 2013-07-31 12:00AM APZ098 2013-07-31 12:00AM APZ283 2013-07-31 12:00AM APM692 2013-07-31 12:00AM APM753 2013-07-31 12:00AM AP6005 2013-07-31 12:00AM APM748 2013-07-31 12:00AM APZ367 2013-07-31 12:00AM APM298 2013-07-31 12:00AM APZ245 2013-07-31 12:00AM AP6053 APZ644 2013-07-31 12:00AM APM524 2013-07-31 12:00AM APZ908 2013-07-31 12:00AM AP6061 2013-07-31 12:00AM APM635 2013-07-31 12:00AM APZ126 2013-07-31 12:00AM APZ298 2013-07-31 12:00AM APZ153 2013-07-31 12:00AM APZ381 2013-07-31 12:00AM AP2315 2013-07-31 12:00AM AP2333 2013-07-31 12:00AM AP2331 2013-07-31 12:00AM AP2332 2013-07-31 12:00AM AP2241 2013-07-31 12:00AM AP2355 2013-07-31 12:00AM APM221 2013-07-31 12:00AM APM844 2013-07-31 12:00AM
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution -- USA, Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Greece, Hong Kong, Israel, Japan, Korea, Luxemburg, Mexico, New Zealand, Norway, Panama, Puerto Rico, Sweden, Taiwan, United Kingdom, Uruguay, and Venezuela.
Product Description
PDS II (polydioxanone) Suture, Ethicon, Inc., A Johnson & Johnson Company, Somerville, NJ. || Sutures are intended for general soft tissue approximation and/or ligation.
Manufacturer
Ethicon, Inc.
1 Event
- Recall of Device Recall PDS II (polydioxanone) Suture

Manufacturer

Ethicon, Inc.

Manufacturer Address
Ethicon, Inc., US Highway 22 West, Somerville NJ 08876
Manufacturer Parent Company (2017)
Johnson & Johnson
Source
USFDA

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