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Class 2 Device Recall TransTissue Product Line |
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| Date Initiated by Firm |
June 01, 2017 |
| Create Date |
August 22, 2017 |
| Recall Status1 |
Terminated 3 on January 30, 2024 |
| Recall Number |
Z-3066-2017 |
| Recall Event ID |
77518 |
| Product Classification |
unknown device name - Product Code N/A
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| Product |
Tissu-Trans SFILL 360, 3-TT-SFILL 360.
Product Usage:
Intended for fat transfer and liposuction.
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| Code Information |
Lot Numbers 12079, 61117, 61143, 61405. |
Recalling Firm/
Manufacturer |
Shippert Medical Technologies
6248 S Troy Cir Ste A
Centennial CO 80111-6485
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Manufacturer Reason
for Recall |
Seal integrity of the Tissu-Trans product sterile packages cannot be assured.
|
FDA Determined
Cause 2 |
Packaging |
| Action |
Customers were notified of the recall between 06/01/2017 and 06/14/2017 via FedEx letter. Instructions included remove and quarantine all affected devices, complete and return the response form, arrange for the return of affected devices, and notify any customers if further distributed. |
| Quantity in Commerce |
5,188 units total |
| Distribution |
Worldwide Distribution - US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, KY, MD, MI, MN, MO, NC, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WV. and the countries of: Italy, Austria, Turkey, United Arab Emirates, Germany, Spain, Saudi Arabia, Switzerland, Japan Kuwait, Denmark, Sweden, United Kingdom, Belgium, France, Australia, Netherlands, Greece, South Korea. |
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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.
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