Recall Z-0752-2019— Collagen Matrix Inc

Name: FDA recall Z-0752-2019
Creator: U.S. Food and Drug Administration
Published: 2018-10-30

Class III · Terminated

Class III FDA medical device recall by Collagen Matrix Inc, initiated 2018-10-30, terminated 2020-05-12. It names one FDA 510(k) clearance: K140714. Product: Porcine Anorganic Bone Mineral 4.0cc. Reason: There is a possibility that the product labeled as 4.0cc volume may only contain 2.0cc volume and is therefore mislabeled..

Recalling firm: Collagen Matrix Inc
Classification: Class III
Status: Terminated
Initiated: 2018-10-30
Terminated: 2020-05-12
Firm location: Oakland, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K140714 — PORCINE ANORGANIC BONE MINERALCollagen Matrix, Inc.·cleared 2014-07-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Porcine Anorganic Bone Mineral 4.0cc

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.