Z-0549-2025Class II

Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular...

Name: Z-0549-2025 Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular...
Creator: Incipio Devices
Published: 2024-10-30
License: https://open.fda.gov/license/

Incipio Devices / initiated 2024-10-30 / Open, Classified / root cause: manufacturing process

FDA source

INCIPIO DEVICES began a recall of Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants on 2024-10-30. FDA classified it as Class II and gives the reason as "Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld". 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-0549-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-10-30
Posted: 2024-11-25
Recalling firm: Incipio Devices
Product: Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Product code: HWA Impactor
Reason for recall: Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Root cause tag: manufacturing process
FDA root cause: Process change control
Action: Consignees were mailed a recall notification titled URGENT ADVISORY NOTICE dated 10/30/2024. The notification instructs consignees to examine their inventory and identify all affected devices for quarantine immediately. Consignees are to complete and return the Recall Response Form to Incipio Devices at [email protected] to facilitate the return of recalled devices and issuance of a FedEx return label. Returned devices should be sent back in their original packaging if unused and properly decontaminated and sterilized if being sent back used. Consignees with any questions should contact Incipio Devices by phone at +41 32 754 34 34 or by email at [email protected].
Quantity in commerce: 100 units
Distribution: US Nationwide distribution in the state of TN.
Product codes and lots: Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0549-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0549-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-12-04	2024-11-25

Product code HWA

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)