Recall Z-1915-2015 ยท HSB Rod, Fixation, Intramedullary And Accessories
Synthes, Inc.
DePuy Synthes 6.5 mm Titanium Recon Screws w/T25 Stardrive (70mm, 75mm, 80mm, 85mm, 90mm, 95mm, 105mm); part of the Expert Lateral Femur Nail System and indicated to stabilize Subtrochanteric fractures, Ipsilateral neck/shaft fractures, Femoral shaft fractures, Impending pathologic fractures, and malunions/Non-unions.
| Date | Jun 26, 2015 (initiated May 27, 2015) |
| Status | Terminated |
| Reason | certain lots of the Titanium Recon Screws (6.5mm ) were found to contain the incorrect insert GP0760-A (Synthes Titanium Buttress Locking Plate System), instead of the correct insert GP0706-E (Synthes Titanium Intramedullary Nails and Components). |
| Root cause | Process control |
| Action | DePuy Synthes sent an Urgent Medical Device Safety Notification, dated May 27, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions Required: Please take the following actions: Review the information listed in this notification. Forward this notice to anyone in your facility that needs to be informed. Complete the attached Verification Section (page 3 of this notification). Please include your name, title, address, telephone number and signature in the spaces provided. Send a copy of the completed Verifi |
| Quantity | 276 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040336 | SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM Synthes (Usa), Apr 12, 2004 |