FDA Medical Device Recalls (openFDA)
Amendia, Inc: Optimus Fixed Awl
- Recall number
- Z-0891-2017
- Recalling firm
- Amendia, Inc
- Product
- Optimus Fixed Awl
- Status
- Terminated
- Initiated
- 2016-11-22
- Posted
- 2016-12-22
- Terminated
- 2017-02-28
- Reason
- Complaints that the tip of the awl broke after impaction during surgery.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 9 devices
- Distribution
- US Distribution to the states of : FL, GA. IL, MO, TX
- Lot, serial or model codes
- Part Number 139005 - Lot Number 182-16146
- 510(k) numbers
- ["K132596"]
- PMA numbers
- not on file
- Product code
- OVD
- Firm FEI
- 3007970248
- Firm city
- Marietta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28