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U.S. Department of Health and Human Services

Class 2 Device Recall Encore Reverse Shoulder Prosthesis (RSP) Socket Insert

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  Class 2 Device Recall Encore Reverse Shoulder Prosthesis (RSP) Socket Insert see related information
Date Initiated by Firm August 08, 2007
Date Posted December 19, 2007
Recall Status1 Terminated 3 on March 10, 2008
Recall Number Z-0185-2008
Recall Event ID 44800
510(K)Number K041066  
Product Classification Shoulder Prosthesis Socket Insert - Product Code KWS
Product Encore¿ Reverse¿ Shoulder Prosthesis (RSP) System, Standard Size 40 RSP Humeral Socket Insert; Catalog #: 508-00-040; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758.
Code Information Lot #: 601482.
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact Customer Service
800-520-8976
Manufacturer Reason
for Recall		 Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.
FDA Determined
Cause 2		 Other
Action Encore notified their sales reps (direct accounts) via telephone and overnight letter on 08/08/07. Encore sales reps were asked to return all outstanding devices, for which they would be given replacements. Notification of implanting surgeons was done by phone and letter (Urgent : Device Recall) between 08/07 and 09/12/07. Implanting surgeons notified of recall and asked to closely monitor patients who had received and already been implanted with the affected lots. If explant was required decision of the surgeons, they were asked to notify the recalling firm.
Quantity in Commerce 25 units.
Distribution Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT.
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 = KWS and Original Applicant = ENCORE MEDICAL, L.P.
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