FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Reverse Shoulder Prosthesis (RSP) device component; 40mm + 4mm RSP Socket Device; Device manufactured by Encore Medical, L.P., Austin, TX 78758.
- Recall number
- Z-1260-2007
- Recalling firm
- Encore Medical, Lp
- Product
- Reverse Shoulder Prosthesis (RSP) device component; 40mm + 4mm RSP Socket Device; Device manufactured by Encore Medical, L.P., Austin, TX 78758.
- Status
- Terminated
- Initiated
- 2007-03-22
- Posted
- 2007-09-25
- Terminated
- 2008-03-27
- Reason
- Marketed without approval: Investigational devices were implanted during an IDE study prior to receiving approval for the devices in the study; patients were implanted with investigational devices outside of the IDE study; and devices implanted as "custom devices" by the manufacturer did not meet the definition of "custom devices" and were, therefore, unapproved devices.
- Root cause
- Other
- Action
- Letters were sent via Certified Mail on 03/22/07 to the surgeons and their associated IRBs. Each letter included a list of the patients to be notified and a form letter that the surgeons could use to notify the patients. Surgeons asked to notify their patients and to provide Encore with documented evidence that patience were notified.
- Quantity
- 8 units.
- Distribution
- Nationwide: Devices sold to and implanted by physicians in CA, CO, FL, GA, NY, SC and TX.
- Lot, serial or model codes
- 0600-292.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28