Recall Z-0677-2019— Howmedica Osteonics Corp.

Name: FDA recall Z-0677-2019
Creator: U.S. Food and Drug Administration
Published: 2018-11-15

Class II · Terminated

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2018-11-15, terminated 2020-06-18. It names one FDA 510(k) clearance: K161447. Product: HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE. Reason: Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19.

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Terminated
Initiated: 2018-11-15
Terminated: 2020-06-18
Firm location: Allendale, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K161447 — HydroSet XTOrthovita, Inc.·cleared 2016-10-06

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

HydroSet XT Injectable HA Bone Cement, REF 897003, STERILE

Reason for recall

Incorrect expiry date of 17-Dec-19 Correct expiry date is 11-Aug-19

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