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Terminated

MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.

FDA Recall Z-0598-06 · Posted 2006-03-09

Recalling FirmOrthohelix Surgical Designs Inc
Recall StatusTerminated
Product CodeHRS
Date Initiated2005-11-01
Date Terminated2012-04-25
Product Quantity14

Reason for Recall

Screwdriver pilot taper tip can break during surgery.

Firm Action

Between 11/1 and 11/7/05, the recalling firm visited 12 of the consignees and collected the product, and phoned the other 2 consignees and requested return of the product.

Root Cause

Other

Distribution Pattern

Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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