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U.S. Department of Health and Human Services

Class 2 Device Recall Offset Cup Impactor

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 Class 2 Device Recall Offset Cup Impactorsee related information
Date Initiated by FirmOctober 30, 2024
Date PostedNovember 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0549-2025
Recall Event ID 95653
Product Classification Impactor - Product Code HWA
ProductOffset Cup Impactor - 3/8-16 interface. Reusable surgical instrument used to position and place acetabular sup implants.
Code Information Product Reference No.: 50341105; UDI-DI: 07630055304735; Lot No.: 24A0087.
Recalling Firm/
Manufacturer		 INCIPIO DEVICES
avenue des Paquiers 16
St-Blaise Switzerland
For Additional Information ContactChris Taylor
004-132-7543434
Manufacturer Reason
for Recall		Recalled lot does not meet specification and has reported incidents of fracture of the TIG weld.
FDA Determined
Cause 2		Process change control
ActionConsignees 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 in Commerce100 units
DistributionUS Nationwide distribution in the state of TN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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