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U.S. Department of Health and Human Services

Class 2 Device Recall MaxLock Screwdriver

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  Class 2 Device Recall MaxLock Screwdriver see related information
Date Initiated by Firm November 01, 2005
Date Posted March 09, 2006
Recall Status1 Terminated 3 on April 25, 2012
Recall Number Z-0598-06
Recall Event ID 34498
Product Classification unknown device name - Product Code HRS
Product MaxLock Screwdriver, part MXS-056. This is a surgical instrument used in conjunction with the MaxLock Plate and Screw System.
Code Information lot #11298
Recalling Firm/
Orthohelix Surgical Designs Inc
1815 W Market Street
Suite 205
Akron OH 44313
For Additional Information Contact Lee A. Strand
Manufacturer Reason
for Recall
Screwdriver pilot taper tip can break during surgery.
FDA Determined
Cause 2
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.
Quantity in Commerce 14
Distribution Ohio, Missouri, Texas, South Dakota, Colorado, New Jersey, Georgia, and Florida.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.