FDA Medical Device Recalls (openFDA)
INCIPIO DEVICES: Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
- Recall number
- Z-0549-2025
- Recalling firm
- INCIPIO DEVICES
- Product
- Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
- Status
- Open, Classified
- Initiated
- 2024-10-30
- Posted
- 2024-11-25
- Terminated
- not on file
- Reason
- Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
- 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 surveillance@incipiodevices.ch 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 surveillance@incipiodevices.ch.
- Quantity
- 100 units
- Distribution
- US Nationwide distribution in the state of TN.
- Lot, serial or model codes
- Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HWA
- Firm FEI
- 3013223655
- Firm city
- St-Blaise
- Firm state
- not on file
- Firm country
- Switzerland
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28