RegenerOss Resorbable Xenograft recallZ-0752-2019 · Collagen Matrix Inc · initiated Oct 30, 2018
Terminated
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
There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
FDA root cause category: Employee error
What the company is doing
On October 30, 2018 Collagen Matrix, notified their 2 distributors of the issue via email. The two distributors provided notices to their customers. Customers were advised to take the following actions: 1. If any of the items noted in the scope of the letter is held in stock, please return them along with a copy of the letter to the address provided. Replacement product will be provided upon receipt of the return. 2. Complete the Certificate of Acknowledgement within 15 days of receipt and email the completed form to the email address noted within your letter.
Recall details
- Recall number
- Z-0752-2019
- Status
- Terminated
- Initiated by the company
- Oct 30, 2018
- Recalling firm
- Collagen Matrix Inc
- Quantity
- 136 units
- Product code
- NPM
- FDA submissions
- K140714
- Distribution
- FL, TX
Product description
Porcine Anorganic Bone Mineral 4.0cc
Code information (models, lots, serial numbers)
UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- RegenerOss Resorbable Xenograft ROXR40Collagen Matrix, Inc. · Bone Grafting Material, Animal Source1 recall1 report
Product lines
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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