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

Recall Insight

This FDA Devices action (record #Z-0737-2023) was formally reported on December 28, 2022, with the manufacturer initiating the action on November 7, 2022. It is classified under Low severity (Class III), with a current status of Ongoing. Howmedica Osteonics Corp. is listed as the recalling firm, operating out of Mahwah, NJ. Federal records indicate 20 units units are affected.

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: International distribution in the country of Turkey.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 4 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.