CLASS II Device recall · Reported 25 May 2016 · FDA Enforcement Report
Anspach, Rx only, Otologic Curved Micro recalled by The Anspach Effort
The Anspach Effort is recalling Anspach, Rx only, Otologic Curved Micro (Occm) Diamond Ball Burr, 1.5, distributed in Kentucky, Texas. The recall was initiated on 28 Mar 2016 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-1667-2016
- FDA event ID
- 73738
- Recalling firm
- The Anspach Effort, Palm Beach Gardens, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Mar 2016
- FDA classified
- 19 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Mar 2016 | Recall initiated by company | |
| 19 May 2016 | Classified by FDA | +52 days |
| 25 May 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
Product as listed by the FDA
ANSPACH, Rx only, Otologic Curved Micro (OCCM) Diamond Ball Burr, 1.5 MM, Part # OCM7-15SD Product Usage: The Otologic Curved Micro (OCCM) Attachment and burrs are intended for cutting and shaping bone primarily in otology procedures such as cochleostomies.
Where it was distributed
US Distribution in the states of KY and TX.
Questions about this recall
Is Anspach, Rx only, Otologic Curved Micro (Occm) Diamond Ball Burr, 1.5 recalled?
Yes. The Anspach Effort recalled Anspach, Rx only, Otologic Curved Micro (Occm) Diamond Ball Burr, 1.5 on 28 Mar 2016. The recall is Class II and its status is Terminated. Recall number Z-1667-2016.
Why was it recalled?
Certain lots of the Otologic Curved Micro (OCM) Diamond Ball Burrs may be missing the diamond coating and the ball may be the incorrect size.
Which lots are affected?
Model/Catalog #:OCM7-15SD, 1.5 MM Diamond Ball, Lot Numbers: J473111704 and J473111705
Where was it sold?
US Distribution in the states of KY and TX.
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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