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U.S. Department of Health and Human Services

Class 2 Device Recall G7 Positioning Guide Rod

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  Class 2 Device Recall G7 Positioning Guide Rod see related information
Date Initiated by Firm May 07, 2014
Date Posted June 19, 2014
Recall Status1 Terminated 3 on October 30, 2015
Recall Number Z-1837-2014
Recall Event ID 68310
510(K)Number K121874  
Product Classification prosthesis, hip, constrained, cemented or uncemented, metal/polymer, + additive - Product Code PBI
Product G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458.
Code Information PN:110003458. Lots 424960, ZB130702, ZB130703, ZB130704, ZB130705, ZB130701, ZB131201, 360877, 377304 and ZB140201.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery.
FDA Determined
Cause 2		 Use error
Action The firm issued the following notice on May 7, 2014: URGENT MEDICAL DEVICE RECALL NOTICE: This notification is to inform you of an Urgent Medical Device Recall initiated by Biomet Orthopedics ("Biomet") which involves Part Numbers: 110003458 G7 Positioning Guide Rod and 110003500 G7 Positioning Guide Post. These instruments have been consigned and/or invoiced to your account. Biomet has initiated this action following an investigation which identified that positioning guide rod may fracture during impaction of the acetabula shell. If the positioning guide rod fractures, then the positioning guide post may become stuck to the insertion handle. There is no adverse health outcome expected for the patient. This action requires the immediate location and discontinued use of the product and its return to Biomet. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed "FAX Back Response Form. Fax a copy of the Response Form to 574-372-1683 prior to return of product. Use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear Risk/Recall Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products.
Quantity in Commerce 1047 total
Distribution Worldwide Distribution-USA (nationwide) and the countries of Canada, Netherlands, New Zealand, and Japan.
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 = PBI and Original Applicant = BIOMET MANUFACTURING CORP.
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