Recall Z-1784-2010 ยท HWC Screw, Fixation, Bone
Orthohelix Surgical Designs Inc
Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. Intended as a guide to normal healing and are not intended to replace normal body structure or bear the weight of the body in the presence of incomplete bone healing.
| Date | Jun 10, 2010 (initiated Mar 23, 2010) |
| Status | Terminated |
| Reason | On 3/9/10 it was discovered that the recalling firm packaged MFT-021-35-24 Screws from lot 0964092 as MFT-021-35-22 lot 0964081. |
| Root cause | Employee error |
| Action | OrthoHelix Surgical Designs, Inc. issued an "Important Field Correction Notice" dated March 23, 2010 via FedEx overnight. They instructed their customers to inventory their stock for affected product. All affected product will be replaced by the firm. For further information, contact OrthoHelix Surgical Designs, Inc. at 1-330-247-1444. |
| Quantity | 62 pieces |
| Distribution | Nationwide Distribution -- AZ, CA, CO, FL, GA, ID, IL, MD, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073624 | MODULAR FOOT SYSTEM Orthohelix Surgical Designs, Inc., Mar 20, 2008 |