Z-0843-2024Class II

Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210

Name: Z-0843-2024 Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Creator: Fx Shoulder
Published: 2023-08-08
License: https://open.fda.gov/license/

Fx Shoulder Solutions Inc. / initiated 2023-08-08 / Open, Classified / root cause: labeling and UDI

FDA source

FX SHOULDER began a recall of Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 on 2023-08-08. FDA classified it as Class II and gives the reason as "Centered glenosphere box may contain an eccentric glenosphere". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0843-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-08
Posted: 2024-01-29
Recalling firm: Fx Shoulder Solutions Inc.
Product: Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: Centered glenosphere box may contain an eccentric glenosphere.
Root cause tag: labeling and UDI
FDA 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 in commerce: 4
Distribution: US Nationwide distribution in the state of NJ.
Product codes and lots: UDI-DI: 03701037309551, Lot: U0191

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0843-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0843-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-02-07	2024-01-29

Product code PHX

K191146Class IIHumelock TiN Coated GlenosphereFx Shoulder USA, Inc. / cleared 2020-07-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)