Recall Z-2184-2020— Osteomed, LLC

Name: FDA recall Z-2184-2020
Creator: U.S. Food and Drug Administration
Published: 2020-04-02

Class II · Terminated

Class II FDA medical device recall by Osteomed, LLC, initiated 2020-04-02, terminated 2021-05-05. It names one FDA 510(k) clearance: K051123. Product: OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.. Reason: Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration..

Recalling firm: Osteomed, LLC
Classification: Class II
Status: Terminated
Initiated: 2020-04-02
Terminated: 2021-05-05
Firm location: Addison, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K051123 — CALLOS IMPACT AND INJECT BONE VOID FILLERSkeletal Kinetics, LLC·cleared 2005-06-03

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

OSTEOVATION 10CC INJECT FORMULA. REF/UDI: 390-2010/00813845020061 - Product Usage: The product provides a bone void filler that is replaced by bone during the healing process.

Reason for recall

Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.

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