Recall Z-1851-2017 ยท GFG Bit, Surgical
Smith & Nephew, Inc.
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
| Date | Mar 15, 2017 |
| Status | Terminated |
| Reason | Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming |
| Root cause | Device Design |
| Action | Smith &n Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com. For questions regarding this recall call 508-261-3600. |
| Distribution | Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.