Date Initiated by Firm |
June 15, 2017 |
Create Date |
January 17, 2018 |
Recall Status1 |
Terminated 3 on March 15, 2018 |
Recall Number |
Z-0383-2018 |
Recall Event ID |
78802 |
510(K)Number |
K153690
|
Product Classification |
Dressing, wound, collagen - Product Code KGN
|
Product |
PriMatrix¿ is an acellular dermal tissue matrix derived from fetal bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.
|
Code Information |
Product Model Number Product Lot Number Product Description Product Model Number Product Lot Number Product Description 607-004-880 1508019 8 x 8 cm 607-005-014 1702023 14mm Disc 607-005-880 1509051 8 x 8 cm 607-005-018 1702024 18mm Disc 607-005-440 1512021 4 x 4 cm 607-005-220 1702025 2 x 2 cm 607-005-812 1512022 8 x 12 cm 607-005-014 1702026 14mm Disc 607-005-440 1603044 4 x 4 cm 607-005-018 1702027 18mm Disc 607-005-660 1606038 6 x 6 cm 607-005-220 1702028 2 x 2 cm 607-001-112 1611044 10 x 12 cm 607-005-014 1702029 14mm Disc 607-001-812 1611045 8 x12 cm 607-005-018 1702030 18mm Disc 607-001-225 1612013 20 x 25 cm 607-005-220 1702031 2 x 2 cm 607-001-009 1612018 0.2 x 26.5 cm 607-005-014 1702032 14mm Disc 607-004-440 1701034 4 x 4 cm 607-005-014 1702033 14mm Disc 607-001-440 1701036 4 x 4 cm 607-005-014 1702034 14mm Disc 607-004-660 1701037 6 x 6 cm 607-005-014 1703007 14mm Disc 607-001-660 1701044 6 x 6 cm 607-005-018 1703008 18mm Disc The affected lots are manufactured from February 2017 to May 2017. The affected lots will expire in 2020 to 2021. |
Recalling Firm/ Manufacturer |
TEI Biosciences 7 Elkins St Boston MA 02127-1601
|
For Additional Information Contact |
617-268-1616
|
Manufacturer Reason for Recall |
During Final Assembly Operation, it was noticed that some of the PriMatrix Instructions for Use (IFUs) from Lot RM1608011 Part 520-002v10 contained extra pages and/or missing pages:
" 22 IFUs contained duplicate pages 15 - 26 & 51 - 62 and were also missing pages 27 - 50
" 3 IFUs were missing pages 27 - 50
" 1 IFU was missing pages 1 - 2 & 75 - 76
" 1 IFU was missing pages 15 - 62
While pages 27 50, 75 76, and 15 62 contain instructions written in a language other than English, pages 1 2 contain information regarding the indications for use, contraindications, device description, warning and precautions, and potential complications of the device.
|
FDA Determined Cause 2 |
Error in labeling |
Action |
Integra LifeSciences Corporation notified (all U.S.) customers via Letter/Medical Device Correction Field Safety Notice dated June 15, 2017. Letter delivered by courier service, facsimile or email July 15, 2017. |
Quantity in Commerce |
4081 units |
Distribution |
U.S. |
Total Product Life Cycle |
TPLC Device Report
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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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510(K) Database |
510(K)s with Product Code = KGN and Original Applicant = TEI BioSciences Inc.
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