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U.S. Department of Health and Human Services

Class 2 Device Recall PROKERA Plus

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  Class 2 Device Recall PROKERA Plus see related information
Date Initiated by Firm November 10, 2020
Create Date December 09, 2020
Recall Status1 Terminated 3 on July 06, 2023
Recall Number Z-0551-2021
Recall Event ID 86807
510(K)Number K032104  
Product Classification Conformer, ophthalmic, biological tissue - Product Code NQB
Product PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
Code Information Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024  Serial ID: 20-PKP-00994,20-PKP-00988,20-PKP-00989,20-PKP-00990,20-PKP-00991,20-PKP-00992,20-PKP-00993,20-PKP-00995,20-PKP-00996, and 20-PKP-00997
Recalling Firm/
Manufacturer		 TissueTech, Inc.
8305 NW 27th St Ste 101
Doral FL 33122-1934
Manufacturer Reason
for Recall		 Potential exposure of product to microbial contamination.
FDA Determined
Cause 2		 Under Investigation by firm
Action Written notification letter titled, "URGENT Medical Device Voluntary Recall Notification PROKERA Self-Retaining Biologic Corneal Bandage" was sent to all consignees on 11/10/2020. Each customer was sent a letter as well as a reconciliation sheet that listed the specific impacted serial IDs from the PROKERA product line (including PROKERA, PROKERA PLUS and PROKERA Slim). The required action's mentioned in the letter include: Notifying the firm via email at customerfeedback@biotissue.com whether the impacted product remains at the consignee's facility using the reconciliation sheet attached to the letter. The letter also mentions for the consignee to discontinue using any remaining units within the impacted lots. Bio-Tissue will provide the consignee with shipping materials to return affected product.
Quantity in Commerce 10 units
Distribution US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.
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 = NQB and Original Applicant = BIO-TISSUE, INC.
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