Optimus Fixed Awl
FDA device recall Z-0891-2017 · posted 2016-12-22 · Terminated
Recall details
- Recalling firm
- Amendia, Inc
- Reason for recall
- Complaints that the tip of the awl broke after impaction during surgery.
- Action taken
- Amendia Inc. sent an Urgent : Medical Device Recall letter dated November 22, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter requested that they examine inventory and quarantine the product. The letter also requested that they contact Amendia to confirm receipt of the letter and to obtain a Return Material Authorization for any product on hand. For further questions, please call (404) 610-7215.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OVD
- Quantity affected
- 9 devices
- Distribution
- US Distribution to the states of : FL, GA. IL, MO, TX
- Date initiated
- 2016-11-22
- Date posted
- 2016-12-22
- Date terminated
- 2017-02-28
- Location
- Marietta, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROPOSED OPTIMUS (K132596) | Custom Spine, Inc. | 2014-04-11 |