Porcine Anorganic Bone Mineral 4.0cc
- Company
- Collagen Matrix Inc
- Recall Initiated
- October 30, 2018
- Terminated
- May 12, 2020
- Recall Number
- Z-0752-2019
- Quantity
- 136 units
- Firm Location
- Oakland, NJ
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.
Distribution
FL, TX
Lot / Code Info
UDI - (01)00813954022369(17)210430(10)PMCU18C4 Lot Number - PMCU18C4 Expiration Date - 04/30/2021
Root Cause
Employee error
Action Taken
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.