Offset Cup Impactor (Incipio Devices) – TIG weld fracture risk (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Brand
INCIPIO DEVICES avenue des Paquiers 16 St-Blaise Switzerland
Lot Codes / Batch Numbers
Product Reference No.: 50341105, UDI-DI: 07630055304735, Lot No.: 24A0087.
Products Sold
Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
INCIPIO DEVICES avenue des Paquiers 16 St-Blaise Switzerland is recalling Offset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acet due to Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026