OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in
FDA device recall Z-0027-2013 · posted 2012-10-09 · Terminated
Recall details
- Recalling firm
- Orthohelix Surgical Designs Inc
- Reason for recall
- The tips of the drivers are breaking while being used to drive the screws into patients.
- Action taken
- The firm, OrthoHelix Surgical Designs, Inc., sent an "IMPORTANT RECALL NOTICE: Mini MaxTorque HCS-056-32 & HCS-056-38 Drivers" dated January 29, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue the use of these drivers immediately and return them to OrthoHelix Surgical Designs Inc, 1065 Medina Rd., Suite 500, Medina, OH 44256; ATTN: Driver Recall. Should you have any questions about system, call 330-247-1145 or the Director of Regulatory Affairs & Quality Assurance at 330-247-1444.
- Root cause
- Software design (manufacturing process)
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 120 Pieces
- Distribution
- Nationwide distribution: USA including the states of CA, CO, FL, GA, IL, MO, NC, NH, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA, and WI.
- Date initiated
- 2010-01-29
- Date posted
- 2012-10-09
- Date terminated
- 2013-02-20
- Location
- Medina, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MAXTORQUE MINI CANNULATED SCREW SYSTEM (K082574) | Orthohelix Surgical Designs, Inc. | 2008-12-08 |