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.
This recall has been terminated (originally issued January 13, 2012).
- Company
- Ortho Development Corporation
- Recall Initiated
- December 19, 2011
- Posted
- January 13, 2012
- Terminated
- August 27, 2012
- Recall Number
- Z-0740-2012
- Quantity
- 37 units
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
Tip of hex-head screwdriver may break off during use in hip replacement procedure.
Distribution
Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT.
Lot / Code Info
Lot numbers 1365304, 1365305.
Root Cause
Device Design
Action Taken
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.