Orthofix Power Drill Torque Limiter Recall: Risk of Breakage During Surgery
Orthofix recalls power drill torque limiters used in surgery due to potential breakage during procedures. Affected products include specific sterile kits and single-use items sold by Galaxy UNYCO.
Stop using this now
The power drill torque limiter may break during use in surgery application.
Contact the company
What happened, in plain English
Orthofix is recalling its Power Drill Torque Limiter, a surgical tool used for temporary bone stabilization. The device may break during surgery, which could lead to complications. Patients using these products should stop using them immediately. Read more at govinfonow.com/recall/73464-orthofix-power-drill-torque-limiter-recall-risk-of-breakage-during.
Source Summary by GovInfoNow · govinfonow.com/recall/73464-orthofix-power-drill-torque-limiter-recall-risk-of-breakage-during · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0291-2018
Cite this page
“Orthofix Power Drill Torque Limiter Recall: Risk of Breakage During Surgery.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73464-orthofix-power-drill-torque-limiter-recall-risk-of-breakage-during. Based on FDA recall #Z-0291-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0291-2018%22&limit=1).
Why it’s dangerous
The torque limiter may break during surgery, potentially causing bone displacement or injury to the patient. This could lead to complications requiring additional surgical intervention.
Who’s affected
Surgical patients and medical professionals who have purchased the recalled Orthofix Power Drill Torque Limiter or associated sterile kits. Those undergoing orthopedic procedures with these products are at the highest risk.
How to tell if you have this one
Check for the product codes and lot numbers listed in the recall notice. The Power Drill Torque Limiter has product code 99-93568. The sterile kits include specific product codes like 99-93506 and 99-93509.
- Brand
Orthofix- Category
Medical device
What to do — step by step
Stop Using Immediately
Discontinue use of the recalled Power Drill Torque Limiter and associated sterile kits if you have them.
Where it went and when
Where it was distributed
Distributed in 3 states, and outside the U.S.
FDA distribution: “Worldwide Distribution -- US, including the states of CA, FL, & PA; and, the countries of Australia, Germany, Finland, France, Italy, Lithuania, Netherlands, Singapore, South Africa, Sweden, Switzerland, & United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Florida, Pennsylvania.
Recall timeline
FDA terminated this recall 5.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0291-2018 (July 5, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0291-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.