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U.S. Department of Health and Human Services

Class 2 Device Recall Turon

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  Class 2 Device Recall Turon see related information
Date Initiated by Firm July 20, 2009
Date Posted September 04, 2009
Recall Status1 Terminated 3 on January 07, 2010
Recall Number Z-1992-2009
Recall Event ID 52701
510(K)Number K081448  
Product Classification Shoulder Metal/Polymer Semi-Constrained Uncemented Prosthesis - Product Code MBF
Product Turon Revision Glenoid Poly Liner.
The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner.

DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.
Code Information Lot numbers: 53987943, 53987944, 53987945, 53987946, and 53987947.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action Firm notified consignees by an Urgent: Medical Device Recall letter, dated July 20, 2009. The letter stated the reason for the recall, asked customers to quarantine, and return the affected product. The enclosed response form needed to be completed and returned as soon as possible. Questions were to be directed to David Harris, Manager of Customer Service at 512-834-6330.
Quantity in Commerce 60 units
Distribution Nationwide Distribution -- Including states of TX, FL, and GA.
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 = MBF and Original Applicant = ENCORE MEDICAL, L.P.
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