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Open, Classified

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

FDA Recall Z-1777-2022 · Posted 2022-09-23

Recalling FirmCollagen Matrix Inc
Recall StatusOpen, Classified
Product CodeKGN
Date Initiated2022-08-03
Product Quantity1336 units

Reason for Recall

The packaging may not be sealed, which could compromise sterility.

Firm 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.

Root Cause

Packaging change control

Distribution Pattern

US distribution to distributors in IL, IN, MI, NC, OH, and TX

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K152600Collagen Dental Wound DressingsCollagen Matrix, Inc. · 2016-06-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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