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Encore Reverse Shoulder Prosthesis (RSP) System, Standard… recallZ-0184-2008 · Encore Medical, Lp · initiated Aug 8, 2007

Terminated All recalls posted in December 2007

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Encore Medical, Lp or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Devices Mislabeled; one lot of Size 36 Standard RSP Socket Inserts were labeled as Size 40 Standard RSP Sockets and vice versa.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0184-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 8, 2007
Posted by the FDA
Dec 19, 2007
Recalling firm
Encore Medical, Lp
Quantity
24 units.
Product code
KWS
FDA submissions
K041066
Distribution
Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT.

Product description

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 (models, lots, serial numbers)

Lot #: 602032.

Other devices under the same FDA submission

14 devices cleared under K041066 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 44800).

Sources and updates

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