Modular Foot System 3.5mm x 22mm Locking Screw M/N: MFT-021-35-22. OrthoHelix Surgical Designs, Inc. Medina, OH 44256. I
FDA device recall Z-1784-2010 · posted 2010-06-10 · Terminated
Recall details
- Recalling firm
- Orthohelix Surgical Designs Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 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.
- Date initiated
- 2010-03-23
- Date posted
- 2010-06-10
- Date terminated
- 2012-09-10
- Location
- Medina, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODULAR FOOT SYSTEM (K073624) | Orthohelix Surgical Designs, Inc. | 2008-03-20 |