CLASS II Device recall · Reported 16 Dec 2020 · FDA Enforcement Report

Prokera Plus, non-sterile recalled by TissueTech

TissueTech is recalling Prokera Plus, non-sterile, distributed nationwide in the US. The recall was initiated on 10 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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

Quantity recalled10 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0551-2021
FDA event ID: 86807
Recalling firm: TissueTech, Doral, FL
Classification: Class II
Status: Terminated
Recall initiated: 10 Nov 2020
FDA classified: 9 Dec 2020
Reported: 16 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

10 Nov 2020	Recall initiated by company
9 Dec 2020	Classified by FDA	+29 days
16 Dec 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Potential exposure of product to microbial contamination.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.

Where it was distributed

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.

Nationwide Alabama Arkansas California Colorado Connecticut District of Columbia Florida Georgia Kansas Kentucky Massachusetts Maryland Maine Michigan Minnesota North Carolina New Jersey New York Ohio Oklahoma

Questions about this recall

Is Prokera Plus, non-sterile recalled?

Yes. TissueTech recalled Prokera Plus, non-sterile on 10 Nov 2020. The recall is Class II and its status is Terminated. Recall number Z-0551-2021.

Why was it recalled?

Potential exposure of product to microbial contamination.

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from TissueTech

All 3

Reported	Class	Recall	Company	Reason	Where
16 Dec 2020Device	CLASS II	Prokera Slim, non-sterile recalled by TissueTech	TissueTech	Sterility	Nationwide
16 Dec 2020Device	CLASS II	Prokera, non-sterile recalled by TissueTech	TissueTech	Sterility	Nationwide

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