Z-1777-2022Class II

Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following...

Name: Z-1777-2022 Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following...
Creator: Collagen Matrix Inc
Published: 2022-08-03
License: https://open.fda.gov/license/

Collagen Matrix, Inc / initiated 2022-08-03 / Open, Classified / root cause: packaging

FDA source

Collagen Matrix Inc began a recall of Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2)... on 2022-08-03. FDA classified it as Class II and gives the reason as "The packaging may not be sealed, which could compromise sterility". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1777-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-08-03
Posted: 2022-09-23
Recalling firm: Collagen Matrix, Inc
Product: Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl Schumacher TAPE, 2.5cm x 7.5cm x 1mm
Product code: KGN Wound Dressing With Animal-Derived Material(S)
Reason for recall: The packaging may not be sealed, which could compromise sterility.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: On August 3, 2022, Collagen Matrix began informing the distributors (initial consignees) to place the lot in question on ship hold. On August 8, 2022, Collagen Matrix began informing distributors by email to return the concerned products. Consignees are asked to return any recalled product to the recalling firm and complete the Certificate of Acknowledgement within 15 days of receipt and return it via email.
Quantity in commerce: 1336 units
Distribution: US distribution to distributors in IL, IN, MI, NC, OH, and TX
Product codes and lots: 1) UDI (1 unit package): +D765RTMTAPE100/$$3250131E1C0070AJ; (10 units package): +D765RTMTAPE101/$$3250131E1C0080AK Cytoplast RTMTAPE, Lot E1C0070A 2) UDI (1 unit package): (01)00366975012616(17)250131(10)BDDWTU211002; (10 units package): (01)10366975012613(17)250131(10)BDDWTU211002 GIBSON Healthcare, REF 5251-194; Lot BDDWTU211002 3) UDI (1 unit package): (01)00813954023571(17)250131(10)BDDWTU211002; (10 units package): (01)10813954023578(17)250131(10)BDDWTU211002 MaxxTape, Ref: XTAPE; Lot BDDWTU211002 4) UDI (1 unit package): (01)00813954022079(17)250131(10)BDDWTU211002; (5 units package): (01)10813954022076(17)250131(10)BDDWTU211002 NEOTAPE, Lot BDDWTU211002 5) UDI (1 unit package): (01)00842517100084(17)250131(10)BDDWTU211002; (10 units package): (01)00842517100077(17)250131(10)BDDWTU211002 Karl Schumacher Dental, REF RCWT0001; Lot BDDWTU211002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1777-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1777-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-10-05	2022-09-23

Product code KGN

K152600UnclassifiedCollagen Dental Wound DressingsCollagen Matrix, Inc. / cleared 2016-06-23

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)