Encore Reverse Shoulder Prosthesis (RSP) System, Standard Size 36 RSP Humeral Socket Insert; Catalog #: 508-00-036; Ster
FDA device recall Z-0184-2008 · posted 2007-12-19 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 24 units.
- Distribution
- Nationwide:Direct accounts and surgeons in the following states: CA, GA, IA, MA, MD, MI, MO, SC, TX and UT.
- Date initiated
- 2007-08-08
- Date posted
- 2007-12-19
- Date terminated
- 2008-03-10
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE REVERSE SHOULDER PROSTHESIS (K041066) | Encore Medical L.P. | 2005-03-24 |