CLASS II ONGOING Device recall · Reported 12 Jul 2023 · FDA Enforcement Report

PriMatrix Fenestrated recalled by TEI Biosciences

TEI Biosciences is recalling PriMatrix Fenestrated, distributed nationwide in the US. The recall was initiated on 23 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesItem No. (UDI-DI): 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), 607-005-220 (10381780357407).

Quantity recalled30,528 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-2078-2023
FDA event ID: 92481
Recalling firm: TEI Biosciences, Boston, MA
Classification: Class II
Status: Ongoing
Recall initiated: 23 May 2023
FDA classified: 3 Jul 2023
Reported: 12 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Other Medical Devices

Timeline

23 May 2023	Recall initiated by company
3 Jul 2023	Classified by FDA	+41 days
12 Jul 2023	Published in enforcement report	+9 days

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

Reason for recall

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).

Where it was distributed

Domestic: Nationwide Distribution.

Nationwide

Questions about this recall

Is PriMatrix Fenestrated recalled?

Yes. TEI Biosciences recalled PriMatrix Fenestrated on 23 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2078-2023.

Why was it recalled?

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

Which lots are affected?

Item No. (UDI-DI): 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), 607-005-220 (10381780357407).

Where was it sold?

Domestic: Nationwide Distribution.

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 TEI Biosciences

All 18

Reported	Class	Recall	Company	Reason	Where
12 Jul 2023Device	CLASS II	SurgiMend PRS recalled by TEI Biosciences	TEI Biosciences	Potency & Assay	Nationwide
12 Jul 2023Device	CLASS II	TissueMend; Advanced Soft Tissue Repair Matrix recalled	TEI Biosciences	Potency & Assay	Nationwide
12 Jul 2023Device	CLASS II	SurgiMend 0; Collagen Matrix for Soft Tissue Reconstruction recalled	TEI Biosciences	Potency & Assay	Nationwide
12 Jul 2023Device	CLASS II	PriMatrix Meshed recalled by TEI Biosciences	TEI Biosciences	Potency & Assay	Nationwide
12 Jul 2023Device	CLASS II	SurgiMend 0; Collagen Matrix for Soft Tissue Reconstruction recalled	TEI Biosciences	Potency & Assay	Nationwide

Other Other Medical Devices recalls

All 13,771

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ortho Aspiration Kit recalled	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Arterial Line Insertion Kit recalled	Medline Industries	Sterility	Nationwide