PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.
FDA Recall Z-0551-2021 · Posted None
Recalling FirmTissueTech, Inc.
Recall StatusTerminated
Product CodeNQB
Date Initiated2020-11-10
Date Terminated2023-07-06
Product Quantity10 units
Reason for Recall
Potential exposure of product to microbial contamination.
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 [email protected] 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.
Root Cause
Under Investigation by firm
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.