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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Lot Codes / Batch Numbers
Lot #: 602032.
Products Sold
Lot #: 602032.
A medical device manufacturer is recalling Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog due to Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026