GIBSON HEALTHCARE recallZ-1777-2022 · Collagen Matrix Inc · initiated Aug 3, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Collagen Matrix Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The packaging may not be sealed, which could compromise sterility.
FDA root cause category: Packaging change control
What the company is doing
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.
Recall details
- Recall number
- Z-1777-2022
- Status
- Open, Classified
- Initiated by the company
- Aug 3, 2022
- Posted by the FDA
- Sep 23, 2022
- Recalling firm
- Collagen Matrix Inc
- Quantity
- 1336 units
- Product code
- KGN
- FDA submissions
- K152600
- Distribution
- US distribution to distributors in IL, IN, MI, NC, OH, and TX
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
4 devices in the FDA device registry whose identifier appears in the recall's code information.
- GIBSON HEALTHCARE 5251-194Benco Dental Supply CO. · Dressing, Wound, Collagen1 recall0 reports
- neotapeCollagen Matrix, Inc. · Dressing, Wound, Collagen1 recall0 reports
- Karl Schumacher TAPE RCWT0001Karl Schumacher Dental Instrument CO., Inc. · Dressing, Wound, Collagen1 recall0 reports
- MaxxTapeCollagen Matrix, Inc. · Dressing, Wound, Collagen1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K152600 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Salvin Dental Specialties ORAPLUG-PKG-10Salvin Dental Specialties, LLC · Wound Dressing With Animal-Derived Material(S)1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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