Z-0113-2024Class II

stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

Name: Z-0113-2024 stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Creator: Tornier, Inc
Published: 2023-09-15
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2023-09-15 / Open, Classified / root cause: manufacturing process

FDA source

Tornier, Inc began a recall of stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502 on 2023-09-15. FDA classified it as Class II and gives the reason as "One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0113-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-15
Posted: 2023-10-13
Recalling firm: TORNIER Inc.
Product: stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Stryker issued an URGENT MEDICAL DEVICE RECALL NOTICE to its consignees on 09/15/2023 by email and letter. The letter explained the issue and the risk. Actions requests were: Check inventory, quarantine, and respond to the notice. Distributors were directed to notify all applicable parties. Stryker is requesting the return of the affected product.
Quantity in commerce: 30 units
Distribution: US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
Product codes and lots: UDI/DI 10846832062017, Lot Number 1756123

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0113-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0113-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-25	2023-10-13

Product code PHX

K161742Class IIAequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidTornier, Inc. / cleared 2016-11-15

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)