Recall Z-1281-2015 ยท FZX Guide, Surgical, Instrument
Synthes, Inc.
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is us
| Date | Mar 16, 2015 (initiated Feb 17, 2015) |
| Status | Terminated |
| Reason | For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site. |
| Root cause | Process control |
| Action | An Urgent Notice: Medical Device Recall, dated February 17, 2015, was sent to all direct consignees and sales consultants instructing them to take the following actions: Take note of the quantity of affected parts in your possession, and then follow ONE of the options for replacement of the affected product: Option 1: Call DePuy Synthes Repair Department at 1-800-288-6698 to schedule a repair for the affected products. Complete the Verification Section following the instructions provided and send a copy of the completed Verification Section to DePuy Synthes by: Fax: 866-723-2823 or Scan/ |
| Quantity | 183 |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.