Recall Z-0740-2012 ยท LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Ortho Development Corporation
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
| Date | Jan 13, 2012 (initiated Dec 19, 2011) |
| Status | Terminated |
| Reason | Tip of hex-head screwdriver may break off during use in hip replacement procedure. |
| Root cause | Device Design |
| 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. |
| Quantity | 37 units |
| Distribution | Nationwide Distribution-including the states of AZ, CA, FL, MI, OR, TX, and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103384 | ESCALADE ACETABULAR CUP SYSTEM Ortho Development, Mar 16, 2011 |