MaxTorque Cannulated Screw Model # MSD-010-55-060S
FDA Recall Z-1250-2010 · Posted 2010-04-06
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Recalling FirmOrthohelix Surgical Designs Inc
Recall StatusTerminated
Product CodeHWC
Date Initiated2009-04-07
Date Terminated2010-10-20
Product Quantity45 pieces
Reason for Recall
A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.
Firm Action
On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification.
For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.
Root Cause
Other
Distribution Pattern
Product was delivered to: CA, CO, GA, NM, NY, OH, VA & 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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