U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
On august 17, 2017, ethicon had decided to initiate a medical device recall
(removal) of the twenty-five (25) lots of vicryl rapidetm (polyglactin 910) suture
that were distributed to the field. during finished goods testing, a suture damage was
identified on a lot of vicryl rapidetm suture. during the course of the subsequent
investigation, the suture also failed knot tensile strength testing.
조치
On August 31, 2017 a Medical Device recall letter (Reference 2210968-08.31.17-003-R) was issued requesting customers to do the following:
1. Examine your inventory immediately to determine if you have product subject to this recall (removal) on hand and quarantine such product(s).
2. Remove the product subject to this recall (removal) and communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed.
3. If any product subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return.
If you have additional questions regarding this recall (removal) or to report any customer complaints, please contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266).
As with any medical device, adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program online, by regular mail or by fax:
" Online: www.fda.gov/medwatch/report.htm
" Regular Mail:
Use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
Mail to: MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
" Fax: 1-800-FDA-0178