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U.S. Department of Health and Human Services

Class 2 Device Recall Lineum HF Torque Handle Limit (Lineum)

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 Class 2 Device Recall Lineum HF Torque Handle Limit (Lineum)see related information
Date Initiated by FirmMarch 12, 2015
Date PostedApril 20, 2015
Recall Status1 Terminated 3 on September 16, 2015
Recall NumberZ-1465-2015
Recall Event ID 70832
Product Classification Wrench - Product Code HXC
ProductLineum HF Torque Handle Limit (Lineum) Model Number 14-525035 P_roduct Usage: Designed to facilitate reconstruction of the cervical and upper thoracic spine using bones screws, locking plugs, and various types of rods, hooks, and lateral connectors.
Code Information 538133 ,538134 ,548080 ,550475 ,552169 ,553131, 553710 ,558873 ,567568 ,569141
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 Commerce148
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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