Z-0773-2024Class II

Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile

Name: Z-0773-2024 Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile
Creator: Tornier, Inc
Published: 2024-01-03
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2024-01-03 / Open, Classified / root cause: packaging

FDA source

Tornier, Inc began a recall of Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile on 2024-01-03. FDA classified it as Class II and gives the reason as "The incorrect device is contained in the labeled package". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0773-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-03
Posted: 2024-01-19
Recalling firm: TORNIER Inc.
Product: Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
Product code: PHX Shoulder Prosthesis, Reverse Configuration
Reason for recall: The incorrect device is contained in the labeled package.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The recalling firm issued letters dated 1/3/2024 via email to sales representatives and distributors and via FedEx to hospitals on 1/3/2024. The letter provided a product description, product issue, potential risks including a photo of the device that should be in the package and a photo of the device that was in the package. The customer actions needed included: (1) Immediately check the inventory for the affected product, remove it from the point of use, and isolate/quarantine it to prevent accidental use; (2) Sign and return the enclosed Business Reply Form by email to confirm receipt of the notification; (3) Upon receipt of the completed Business Reply Form, the firm will contact the customer to arrange for return of the product; (4) If the product has been further distributed, notify the applicable parties at once about the recall. If possible, inform the recalling firm if any of the devices have been distributed to other organizations, including contact details. If the letter recipient is a distributor, they are responsible for notifying their affected customers.
Quantity in commerce: 50
Distribution: Distribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no military/government distribution. Foreign distribution was made to Australia, France, and Italy.
Product codes and lots: Batch lot codes 6714AZ, serial numbers 001 to 050: 6714AZ001, 6714AZ002, 6714AZ003, 6714AZ004, 6714AZ005, 6714AZ006, 6714AZ007, 6714AZ008, 6714AZ009, 6714AZ010, 6714AZ011, 6714AZ012, 6714AZ013, 6714AZ014, 6714AZ015, 6714AZ016, 6714AZ017, 6714AZ018, 6714AZ019, 6714AZ020, 6714AZ021, 6714AZ022, 6714AZ023, 6714AZ024, 6714AZ025, 6714AZ026, 6714AZ027, 6714AZ028, 6714AZ029, 6714AZ030, 6714AZ031, 6714AZ032, 6714AZ033, 6714AZ034, 6714AZ035, 6714AZ036, 6714AZ037, 6714AZ038, 6714AZ039, 6714AZ040, 6714AZ041, 6714AZ042, 6714AZ043, 6714AZ044, 6714AZ045, 6714AZ046, 6714AZ047, 6714AZ048, 6714AZ049, 6714AZ050; GTIN 00846832091614.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0773-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0773-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-31	2024-01-19

Product code PHX

K183696Class IIAequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed GlenoidTornier, Inc. / cleared 2019-01-30

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)