U-Joint Hex Head Driver 3.5mm, Part Number 228-0016, for the Escalade Acetabular Cup System. Driver is included in Part Number 270-9004-Escalade Acetabular Prep Kit and Part Number 228-9001-Triplus Acetabular Instrument Kit. The Acetabular Cup System is indicated for use in total hip arthroplasty procedures where the means of cup fixation is uncemented, biological fixation. The Hex Head Drive is used to place the screw that affixes the acetabular cup to the hip acetabulum.
FDA Recall Z-0740-2012 · Posted 2012-01-13
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Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeLZO
Date Initiated2011-12-19
Date Terminated2012-08-27
Product Quantity37 units
Reason for Recall
Tip of hex-head screwdriver may break off during use in hip replacement procedure.
Firm Action
Ortho Development Corporation sent an "URGENT!! DEVICE RECALL" letter dated December 19, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check to see if they have the affected device. Customers who have the device are to return the device to the firm, immediately. The firm will provide suitable replacements. Contact the Regulatory Affairs Manager for questions regarding this notice.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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