FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
- Recall number
- Z-0798-2011
- Recalling firm
- Encore Medical, Lp
- Product
- Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
- Status
- Terminated
- Initiated
- 2010-11-05
- Posted
- 2010-12-22
- Terminated
- 2011-04-05
- Reason
- Complaints of fracturing were reported for trial products.
- Root cause
- Device Design
- Action
- Encore Medical notified consignees by letter on 11/5/2010.
- Quantity
- 425 units
- Distribution
- TX, FL, SC, GA
- Lot, serial or model codes
- Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034, 804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045
- 510(k) numbers
- ["K080402"]
- 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