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U.S. Department of Health and Human Services

Class 2 Device Recall Torque Limiting Handle (Aspen/ Alpine)

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 Class 2 Device Recall Torque Limiting Handle (Aspen/ Alpine)see related information
Date Initiated by FirmMarch 12, 2015
Date PostedApril 20, 2015
Recall Status1 Terminated 3 on September 16, 2015
Recall NumberZ-1466-2015
Recall Event ID 70832
Product Classification Wrench - Product Code HXC
ProductTorque Limiting Handle (Aspen/ Alpine) Model Number 6200-1109 Product Usage: Provides posterior fixation in the non-cervical spine with an interspinous fixation device.
Code Information 538133,538134,548080,550475,552169,553131,553710,558873,567568,569141  Part Number: 6200-1109 2009300344 to 2009300543  2009300544 to 2009300643  2009300644 to 2009300743  2009300744 to 2009300843  2009300844 to 2009300993  2009411328 to 2009411377  2010082160 to 2010082257  2010152507 to 2010152571  2010373025 to 2010373174 
Recalling Firm/
Manufacturer		 Biomet Spine, LLC
310 Interlocken Pkwy Ste 120
Broomfield CO 80021-3464
For Additional Information ContactMike J. Medina
303-443-7500 Ext. 244
Manufacturer Reason
for Recall		Biomet is recalling the Lineum HF Torque Handle Limit (Lineum) and Torque Limiting Handle (Aspen/ Alpine) due to the supplier withdrawing it from the market for component updates or reconfiguration.
FDA Determined
Cause 2		Component design/selection
ActionBiomet sent an Urgent Medical Device Recall Notice dated March 12, 2015 via phone and customer letters. The letter identified the affected product, problem and actions to be taken. Customers were asked to follow the instructions on the enclosed "Response Form". For questions call 858-232-2672.
Quantity in Commerce874
DistributionWorldwide Distribution - US Nationwide
Total Product Life CycleTPLC Device Report
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.
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