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U.S. Department of Health and Human Services

Class 2 Device Recall LOW PROFILE NONLOCK SCREW

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  Class 2 Device Recall LOW PROFILE NONLOCK SCREW see related information
Date Initiated by Firm March 18, 2015
Date Posted April 14, 2015
Recall Status1 Terminated 3 on December 11, 2015
Recall Number Z-1446-2015
Recall Event ID 70837
510(K)Number K112345  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component, metal composite - Product Code LXT
Product LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222;
LOT RM105E.

Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Code Information REF 131227222 LOT RM105E
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1570
Manufacturer Reason
for Recall		 A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 3/18/2015, Biomet issued an URGENT MEDICAL DEVICE RECALL NOTICE to affected distributors and one medical facility. Notification included the reason for recall, description of affected product, statement of no expected patient health risk, and actions required of the addressee. Questions related to the recall notification should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 45
Distribution Nationwide Distribution-including the states of CA, IA, NY, FL, PA, UT, NC, SC, KY, CO, MA, GA, WA, TX, OK, and IL.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = LXT and Original Applicant = MEDOS INTERNATIONAL SARL
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