Z-0550-2021Class II

PROKERA, non-sterile -

Name: Z-0550-2021 PROKERA, non-sterile -
Creator: TissueTech, Inc.
Published: 2020-11-10
License: https://open.fda.gov/license/

BioTissue Holdings Inc. / initiated 2020-11-10 / Terminated / root cause: sterility

FDA source

TissueTech, Inc. began a recall of PROKERA, non-sterile - Product Usage: Biologic corneal bandage on 2020-11-10. FDA classified it as Class II and gives the reason as "Potential exposure of product to microbial contamination". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0550-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-10
Posted: 2020-12-09
Terminated: 2023-07-06
Recalling firm: BioTissue Holdings Inc.
Product: PROKERA, non-sterile - Product Usage: Biologic corneal bandage.
Product code: NQB Conformer, Ophthalmic, Biological Tissue
Reason for recall: Potential exposure of product to microbial contamination.
Root cause tag: sterility
FDA 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 [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.
Quantity in commerce: 63 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.
Product codes and lots: Lot Codes: BTR192864, BTR194678, BTR192872, BTR193024 Serial ID: 20-PK16-00761,20-PK16-00762,20-PK16-00763,20-PK16-00767,20-PK16-00796,20-PK16-00797,20-PK16-00798,20-PK16-00803,20-PK16-00815,20-PK16-00816,20-PK16-00817,20-PK16-00818,20-PK16-00819,20-PK16-00759,20-PK16-00760,20-PK16-00808,20-PK16-00809,20-PK16-00781,20-PK16-00820,20-PK16-00791,20-PK16-00792,20-PK16-00804,20-PK16-00805,20-PK16-00806,20-PK16-00807,20-PK16-00810,20-PK16-00811,20-PK16-00812,20-PK16-00813,20-PK16-00814,20-PK16-00768,20-PK16-00769,20-PK16-00782,20-PK16-00783,20-PK16-00778,20-PK16-00770,20-PK16-00771,20-PK16-00772,20-PK16-00773,20-PK16-00774,20-PK16-00775,20-PK16-00776,20-PK16-00777,20-PK16-00765,20-PK16-00779,20-PK16-00780,20-PK16-00799,20-PK16-00800,20-PK16-00793,20-PK16-00794,20-PK16-00795,20-PK16-00784,20-PK16-00785,20-PK16-00801,20-PK16-00764,20-PK16-00821,20-PK16-00789,20-PK16-00790,20-PK16-00766,20-PK16-00786,20-PK16-00787,20-PK16-00788, and 20-PK16-00802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0550-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0550-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-09
Z-0551-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-09
Z-0552-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-09

Product code NQB

K032104Class IIAmniolensBio-Tissue, Inc. / cleared 2003-12-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)