Porcine Anorganic Bone Mineral 4.0cc
FDA Recall Z-0752-2019 · Posted None
Recalling FirmCollagen Matrix Inc
Recall StatusTerminated
Product CodeNPM
Date Initiated2018-10-30
Date Terminated2020-05-12
Product Quantity136 units
Reason for Recall
There is a possibility that the product labeled as 4.0cc
volume may only contain 2.0cc volume and is therefore mislabeled.
Firm Action
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.
Root Cause
Employee error
Distribution Pattern
FL, TX
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.