Z-3309-2024Class II

Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

Name: Z-3309-2024 Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Creator: Tornier, Inc
Published: 2024-08-29
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2024-08-29 / Open, Classified

FDA source

Tornier, Inc began a recall of Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty on 2024-08-29. FDA classified it as Class II and gives the reason as "Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-3309-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-29
Posted: 2024-09-27
Recalling firm: TORNIER Inc.
Product: Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Product code: PAO Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
Reason for recall: Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
FDA root cause: Under Investigation by firm
Action: Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via email. The notice explained the issue, potential risk, and requested the following actions be taken: Identify and isolate the affected units, and respond to the notice via email. Upon receipt of the response, Stryker will arrange for the return of the device. Those consignees who further distributed the product (to other sites or customers) were directed to notify those parties. For questions or concerns, contact: [email protected].
Quantity in commerce: 38 units
Distribution: US Nationwide distribution.
Product codes and lots: GTIN 00846832084494, Batch Lot # 1495AY

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3309-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3309-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-09	2024-09-27

Product code PAO

K201315Class IIPERFORM Humeral System – StemTornier, Inc. / cleared 2020-09-11

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)