CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone recalled
The Anspach Effort is recalling ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone, distributed nationwide in the US. The recall was initiated on 4 Mar 2011 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-1377-2013
- FDA event ID
- 64886
- Recalling firm
- The Anspach Effort, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2011
- FDA classified
- 24 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Mar 2011 | Recall initiated by company | |
| 24 May 2013 | Classified by FDA | +812 days |
| 5 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Product as listed by the FDA
***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone.
Where it was distributed
Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIllinoisIndianaKansasKentuckyLouisianaMarylandMichiganMinnesotaMissouriNorth Carolina
Questions about this recall
Is ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone recalled?
Yes. The Anspach Effort recalled ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone on 4 Mar 2011. The recall is Class II and its status is Terminated. Recall number Z-1377-2013.
Why was it recalled?
Due to three batches of product may have diamond grit size larger than intended applied to the head of the cutting burr.
Which lots are affected?
Lots numbers: D433040800, D403040236, D383039472.
Where was it sold?
Worldwide Distribution-USA (nationwide) including DC and the states of OH, TX, IL, CA, GA, KY, FL, WI, NC, VA, WI, MN, MD, KS, OK, PA, OR ,HI, AZ, WA, TN, AR, IA, MI, CO, LA, NJ, IN, WV, MO, AL, NY, VT, and SC and the countries of France, Canada, Great Britain, Mexico, Australia, Sweden and Netherlands.
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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