FDA Medical Device Recalls (openFDA)
Amendia, Inc: Mac Pin Non-Cannulated Screw, 6.5 x 60mm
- Recall number
- Z-0325-2018
- Recalling firm
- Amendia, Inc
- Product
- Mac Pin Non-Cannulated Screw, 6.5 x 60mm
- Status
- Terminated
- Initiated
- 2017-07-07
- Posted
- not on file
- Terminated
- 2019-10-15
- Reason
- Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, the pins are 60 mm in length.
- Root cause
- Process control
- Action
- Customers were sent recall notification letters on 07/07/2017. Instructions included to examine inventory and quarantine affected products, notify customers if affected products were further distributed, coordinate the return of affected products back to Amendia, and to complete and return the questionnaire. If there are questions, Amendia Customer Service can be contacted at 770-575-5224.
- Quantity
- 41 screws
- Distribution
- Distribution to Georgia, USA.
- Lot, serial or model codes
- Model #85-6560-1, Lot #132117
- 510(k) numbers
- ["K153152"]
- PMA numbers
- not on file
- Product code
- NKB
- 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