CLASS II Device recall · Reported 4 Sep 2024 · FDA Enforcement Report
iBur Diamond Round, Distal Bend - intended to cut bone recalled
Stryker is recalling Stryker iBur Diamond Round, Distal Bend - intended to cut bone in the following manner, distributed nationwide in the US. The recall was initiated on 24 Jul 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2725-2024
- FDA event ID
- 95040
- Recalling firm
- Stryker, Portage, MI
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 24 Jul 2024
- FDA classified
- 26 Aug 2024
- Reported
- 4 Sep 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Spinal Implants
Timeline
| 24 Jul 2024 | Recall initiated by company | |
| 26 Aug 2024 | Classified by FDA | +33 days |
| 4 Sep 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling, reaming, decorticating, shaping, dissecting, shaving, and smoothing for the following medical applications: Neuro; Spine; Ear, Nose, and Throat (ENT)/ Otorhinolaryngology; and Endoscopic applications Ref: 8431-012-030D
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.
Questions about this recall
Is iBur Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling recalled?
Yes. Stryker recalled iBur Diamond Round, Distal Bend - intended to cut bone in the following manner: drilling on 24 Jul 2024. The recall is Class II and its status is Completed. Recall number Z-2725-2024.
Why was it recalled?
Potential for the product to exhibit temperatures higher than specification where the bur shank meets the distal bushing. Temperatures higher than specification may lead to the potential for minor tissue/structure damage or tissue/structure damage from thermal injury which may need medical/surgical intervention.
Which lots are affected?
GTIN: 7613327501230 Lot Numbers: 22216017 22230017 22334017 23004017 23004027 23009017 23157017 23208017 23233017 23233027 24003017
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Australia, Canada, France, Hong Kong, India, Italy, Japan, Japan, Netherlands, South Korea, Spain, Sweden, Taiwan, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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