Recall Z-0240-2023— Howmedica Osteonics Corp.

Name: FDA recall Z-0240-2023
Creator: U.S. Food and Drug Administration
Published: 2022-10-21

Class II · Ongoing

Class II FDA medical device recall by Howmedica Osteonics Corp., initiated 2022-10-21. It names one FDA 510(k) clearance: K123081. Product: Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010. Reason: Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010).

Recalling firm: Howmedica Osteonics Corp.
Classification: Class II
Status: Ongoing
Initiated: 2022-10-21
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K123081 — BONOS R GENTA 1X20 MODEL 01-0228; BONOS R GENTA 2X20 MODEL 01-0229; BONOS R GENTA 1X40 MODEL 01-0217; BONOS R GENTA 2X40Aap Biomaterials GmbH & Co. KG·cleared 2013-03-07

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

Simplex HV With Gentamicin CE, 10 PACK-Bone cement with Gentomycin Catalog Number: 6193-1-010

Reason for recall

Simplex HV With Gentamicin CE, 10 PACKS (P/N 6193-1-010) were distributed to customers who had ordered Simplex HV With Gentamicin in US, 10 PACKS (P/N 6195-1-010)

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