FDA Medical Device Recalls (openFDA)
Collagen Matrix Inc: Porcine Anorganic Bone Mineral 4.0cc
- Recall number
- Z-0752-2019
- Recalling firm
- Collagen Matrix Inc
- Product
- Porcine Anorganic Bone Mineral 4.0cc
- Status
- Terminated
- Initiated
- 2018-10-30
- Posted
- not on file
- Terminated
- 2020-05-12
- Reason
- There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled.
- Root cause
- Employee error
- 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.
- Quantity
- 136 units
- Distribution
- FL, TX
- Lot, serial or model codes
- UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021
- 510(k) numbers
- ["K140714"]
- PMA numbers
- not on file
- Product code
- NPM
- Firm FEI
- 3008817245
- Firm city
- Oakland
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28