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.
FDA Recall Z-0185-2008 · Posted 2007-12-19
Advertisement
Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeKWS
Date Initiated2007-08-08
Date Terminated2008-03-10
Product Quantity25 units.
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.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement