Z-1250-2010

MaxTorque Cannulated Screw Model # MSD-010-55-060S

Name: Z-1250-2010 MaxTorque Cannulated Screw Model # MSD-010-55-060S
Creator: Orthohelix Surgical Designs Inc
Published: 2009-04-07
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2009-04-07 / Terminated

FDA source

Orthohelix Surgical Designs Inc began a recall of MaxTorque Cannulated Screw Model # MSD-010-55-060S on 2009-04-07. The reason FDA records is "A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1250-2010
Status: Terminated
Initiated: 2009-04-07
Posted: 2010-04-06
Terminated: 2010-10-20
Recalling firm: TORNIER Inc.
Product: MaxTorque Cannulated Screw Model # MSD-010-55-060S
Product code: HWC Screw, Fixation, Bone
Reason for recall: A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.
FDA root cause: Other
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.
Quantity in commerce: 45 pieces
Distribution: Product was delivered to: CA, CO, GA, NM, NY, OH, VA & WA.
Product codes and lots: Model # MSD-010-55-060S

Product code HWC

K060428Class IICss Cannulated Screw SystemOrthohelix Surgical Designs, Inc. / cleared 2006-03-07

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)