Severity
Low
LowClass IIIOngoing
FDA Devices recall · Reported December 28, 2022
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001
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 i…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Howmedica Osteonics Corp. recalled Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to livi… - a low-severity action.
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to livi… was recalled by Howmedica Osteonics Corp. in December 28, 2022. Reason: Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Alth…. Check the official notice for the remedy. Verify recall #Z-0737-2023 with the FDA Devices before acting.
The recall
Howmedica Osteonics Corp. issued this low-severity FDA Devices recall-Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Alth….
- Low
- severity level
- 20 units
- affected scope
- Class III
- classification
- December 28, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0737-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 20 units.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
20 units
Related Recalls
6
3 from same agency
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Ongoing |
| Recall number | Z-0737-2023 |
| Date reported | December 28, 2022 |
| Date initiated | November 7, 2022 |
| Recalling firm | Howmedica Osteonics Corp. |
| Firm location | Mahwah, NJ |
| Affected scope | 20 units |
| Distribution | International distribution in the country of Turkey. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0737-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001. Recalled by Howmedica Osteonics Corp.. Units affected: 20 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 28, 2022. Severity: Low. Recall number: Z-0737-2023.
Where was the recalled product distributed? ▼
Distribution: International distribution in the country of Turkey..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0737-2023) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 28, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.