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.
FDA Recall Z-1784-2010 · Posted 2010-06-10
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Recalling FirmOrthohelix Surgical Designs Inc
Recall StatusTerminated
Product CodeHWC
Date Initiated2010-03-23
Date Terminated2012-09-10
Product Quantity62 pieces
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.
Firm 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.
Root Cause
Employee error
Distribution Pattern
Nationwide Distribution -- AZ, CA, CO, FL, GA, ID, IL, MD, NC, NJ, NM, NY, OH, OK, PA, SC, TX, UT, VA and WA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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