CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report
Optimus Fixed Awl recalled by Amendia
Amendia is recalling Optimus Fixed Awl, distributed in Florida, Georgia, Illinois, Missouri, Texas. The recall was initiated on 22 Nov 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-0891-2017
- FDA event ID
- 75856
- Recalling firm
- Amendia, Marietta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Nov 2016
- FDA classified
- 22 Dec 2016
- Reported
- 28 Dec 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 22 Nov 2016 | Recall initiated by company | |
| 22 Dec 2016 | Classified by FDA | +30 days |
| 28 Dec 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
Complaints that the tip of the awl broke after impaction during surgery.
Product as listed by the FDA
Optimus Fixed Awl
Where it was distributed
US Distribution to the states of : FL, GA. IL, MO, TX
Questions about this recall
Is Optimus Fixed Awl recalled?
Yes. Amendia recalled Optimus Fixed Awl on 22 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0891-2017.
Why was it recalled?
Complaints that the tip of the awl broke after impaction during surgery.
Which lots are affected?
Part Number 139005 - Lot Number 182-16146
Where was it sold?
US Distribution to the states of : FL, GA. IL, MO, 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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