Z-3155-2024Class II

stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total...

Name: Z-3155-2024 stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total...
Creator: Tornier, Inc
Published: 2024-08-29
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2024-08-29 / Open, Classified / root cause: sterility

FDA source

Tornier, Inc began a recall of stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder on 2024-08-29. FDA classified it as Class II and gives the reason as "One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-3155-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-29
Posted: 2024-09-16
Recalling firm: TORNIER Inc.
Product: stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
Product code: PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Reason for recall: One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributor were directed to notify their customers. Stryker issued an URGENT: MEDICAL DEVICE RECALL notice to its consignees on 08/29/2024 via mail and email. The notice explained the issue, potential risk, and requested the following actions be taken: identify and isolate all affected product to prevent accidental use, and complete and return the response form. Upon receipt, Stryker will contact the consignee and arrange for the return of the product. Distributors were directed to notify their customers. For questions or concerns, please contact [email protected].
Quantity in commerce: 5 units
Distribution: US Nationwide distribution in the states of IL, WI, AZ, NV, SD.
Product codes and lots: UDI/DI 00846832092192, Lot number 3268BA

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3155-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3155-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-09-25	2024-09-16

Product code PKC

K220418Class IITornier Perform Humeral System – StemlessTornier, Inc. / cleared 2022-09-14

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)