Recall Z-0736-2023— Howmedica Osteonics Corp.

Name: FDA recall Z-0736-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-07

Class III · Ongoing

Class III FDA medical device recall by Howmedica Osteonics Corp., initiated 2022-11-07. It names one FDA 510(k) clearance: K002652. Product: Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001. Reason: Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate..

Recalling firm: Howmedica Osteonics Corp.
Classification: Class III
Status: Ongoing
Initiated: 2022-11-07
Firm location: Mahwah, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K002652 — SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACIIStryker Corp.·cleared 2001-01-26

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

Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

Reason for recall

Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

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