FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
- Recall number
- Z-1566-05
- Recalling firm
- Encore Medical, Lp
- Product
- Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
- Status
- Terminated
- Initiated
- 2005-07-28
- Posted
- 2005-09-21
- Terminated
- 2007-04-19
- Reason
- Incorrect alignment markings or no markings at all on a reverse shoulder prosthesis unit.
- Root cause
- Other
- Action
- Recall was initiated by letter to sales agents on 07/28/2005.
- Quantity
- 93 primary units and 56 revision units
- Distribution
- not on file
- Lot, serial or model codes
- Catalog number: 506-00-006, lot numbers: 260212, 260222, and 244642; Catalog number: 506-00-007, lot number: 250272; Catalog number: 506-00-008, lot numbers: 260242, 254342, 260252, 244662, and 244312; Catalog number: 507-06-175, lot numbers: 261832, 244732, 967721, and 006192; Catalog number: 507-08-175, lot numbers: 261842, 241392, 872681, and 872671
- 510(k) numbers
- ["K041066"]
- PMA numbers
- not on file
- Product code
- JWH
- 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