|
Class 2 Device Recall SYNTHECEL Dura Repair |
|
Date Initiated by Firm |
December 08, 2015 |
Create Date |
October 11, 2018 |
Recall Status1 |
Terminated 3 on August 26, 2016 |
Recall Number |
Z-1384-2016 |
Recall Event ID |
73559 |
510(K)Number |
K113071 K131792
|
Product Classification |
Dura substitute - Product Code GXQ
|
Product |
SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults. |
Code Information |
SYNTHECEL Dura Repair 2.5 cm x 7.5 cm (1x3), part numbers: SC.400.019.01S, Lot Numbers: 7840492, 7855337, 7860565, 7880949, 7901437, 7909570, 7922341 |
Recalling Firm/ Manufacturer |
Synthes (USA) Products LLC 1301 Goshen Pkwy West Chester PA 19380-5986
|
For Additional Information Contact |
David Carvin 610-719-5443
|
Manufacturer Reason for Recall |
It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.
|
FDA Determined Cause 2 |
Labeling False and Misleading |
Action |
Siemens mailed out an Urgent: Field Safety Notification letter informing customers to review the replacement package insert (GP2715-C) and discard the outdated package insert (GP2715-B) and outdated promotional materials. Customers were asked to complete the verification section (page 3 of the recall notification) and send a copy of the completed Verification Section by Fax (888)912-7351 or Scan/Email to Synthes5875@stericycle.com |
Quantity in Commerce |
200 units |
Distribution |
Nationwide: NY, PA, AL, WI, FL, MO, TN, OH, MI, MN, CO, CA, NV, AZ, LA, OR, TX, IA, IN, MS, IL, AR, WV, HI, VA, MD, WA, OK, MA, KY, NJ, CT, No foreign accounts. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GXQ and Original Applicant = SYNTHES 510(K)s with Product Code = GXQ and Original Applicant = SYNTHES INC
|
|
|
|