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U.S. Department of Health and Human Services

Class 2 Device Recall Reverse Shoulder Prosthesis device components

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  Class 2 Device Recall Reverse Shoulder Prosthesis device components see related information
Date Initiated by Firm March 22, 2007
Date Posted September 25, 2007
Recall Status1 Terminated 3 on March 27, 2008
Recall Number Z-1251-2007
Recall Event ID 37874
Product Classification Prosthesis device components - Product Code KWS
Product Reverse Shoulder Prosthesis (RSP) custom device component; 36mm Glenoid Head, Hooded; Custom device manufactured by Encore Medical, L.P., Austin, TX 78758.
Code Information 0700-036.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-834-6235
Manufacturer Reason
for Recall		 Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.
FDA Determined
Cause 2		 Other
Action Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.
Quantity in Commerce 20 units.
Distribution Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
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.
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