Howmedica Osteonics Corp.: Medical Device Recall in 2022 - (Recall #: Z-0737-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

Product Classification:

Class III

Date Initiated: November 7, 2022

Date Posted: December 28, 2022

Recall Number: Z-0737-2023

Event ID: 91147

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.

Status: Ongoing

Product Quantity: 20 units

Code Information:

UDI# P/N 6197-1-001 (01)07613327128741 (17)230331(10)lot# GTIN: 07613327128741-Instructions for Use (IFU) received with product: 0700-7-012 (IFU Radiopaque Bone Cement) All lots manufactured under Rev AB, which with expiration date on/after October 28, 2021

Distribution Pattern:

International distribution in the country of Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated