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
|
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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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