FDA Medical Device Recalls (openFDA)
TissueTech, Inc.: PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
- Recall number
- Z-0551-2021
- Recalling firm
- TissueTech, Inc.
- Product
- PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
- Status
- Terminated
- Initiated
- 2020-11-10
- Posted
- not on file
- Terminated
- 2023-07-06
- Reason
- Potential exposure of product to microbial contamination.
- Root cause
- 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
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K032104"]
- PMA numbers
- not on file
- Product code
- NQB
- Firm FEI
- 3009809074
- Firm city
- Doral
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28