FDA Medical Device Recalls (openFDA)
FX SHOULDER: Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
- Recall number
- Z-0843-2024
- Recalling firm
- FX SHOULDER
- Product
- Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
- Status
- Open, Classified
- Initiated
- 2023-08-08
- Posted
- 2024-01-29
- Terminated
- not on file
- Reason
- Centered glenosphere box may contain an eccentric glenosphere.
- Root cause
- Labeling mix-ups
- Action
- On 8/8/23, the firm telephoned the customer and informed them of the recall. The customer was asked to quarantine the device, which was subsequently collected by the firm.
- Quantity
- 4
- Distribution
- US Nationwide distribution in the state of NJ.
- Lot, serial or model codes
- UDI-DI: 03701037309551, Lot: U0191
- 510(k) numbers
- ["K191146"]
- PMA numbers
- not on file
- Product code
- PHX
- Firm FEI
- 3014128390
- Firm city
- Dallas
- Firm state
- TX
- 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