| Class 2 Device Recall Encore Reverse Shoulder Prosthesis (RSP) Socket Insert | |
Date Initiated by Firm | August 08, 2007 |
Date Posted | December 19, 2007 |
Recall Status1 |
Terminated 3 on March 10, 2008 |
Recall Number | Z-0184-2008 |
Recall Event ID |
44800 |
510(K)Number | K041066 |
Product Classification |
Shoulder Prothesis Socket Insert - Product Code KWS
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Product | Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Sterile; Manufactured by Encore, Medical, L.P., Austin, TX 78758. |
Code Information |
Lot #: 602032. |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
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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 | 24 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 |
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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.
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510(K) Database | 510(K)s with Product Code = KWS
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