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U.S. Department of Health and Human Services

Class 2 Device Recall Modulift VBR Medium Set Screwdrivers

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  Class 2 Device Recall Modulift VBR Medium Set Screwdrivers see related information
Date Initiated by Firm October 25, 2021
Create Date July 19, 2022
Recall Status1 Open3, Classified
Recall Number Z-1410-2022
Recall Event ID 90544
Product Classification Screwdriver - Product Code HXX
Product MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Code Information UDI-DI: 04046964067648
Recalling Firm/
Manufacturer		 Aesculap Implant Systems LLC
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Customer Service
866-229-3002
Manufacturer Reason
for Recall		 Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
FDA Determined
Cause 2		 Component design/selection
Action An Urgent Medical Device Removal Notification was issued October 25, 2021 sent via email and USPS certified mail. The notice identified the product MODULIFT VBR SZ.M 4MM SET SCREWDRIVER, part of Modulift VBR Medium Instrument Set, ST-0441 and requested customers identify and quarantine affected inventory, submit the acknowledgement form and contact AIS Customer Service to arrange for return of product at (866) 229-3002 and SetWorld_orders.BBMUS_Service@aesculapimplants.com. Distributors are to notify customers if product was further distributed.
Quantity in Commerce 9 pieces
Distribution US: CA, FL, GA, IL, OH & MI
Total Product Life Cycle TPLC 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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