FDA Medical Device Recalls (openFDA)
Encore Medical, LP: djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
- Recall number
- Z-1692-2020
- Recalling firm
- Encore Medical, LP
- Product
- djosurgical Linear Neck Trials with Spring Sides, Standard, nonsterile, REF S-200635; and djosurgical Linear Neck Trials with Spring Sides, Lateral, nonsterile, REF S-200636. The firm name on the label is djosurgical, Austin, TX.
- Status
- Open, Classified
- Initiated
- 2018-07-10
- Posted
- not on file
- Terminated
- not on file
- Reason
- The retaining ring on the neck trials has a potential to fail interoperatively.
- Root cause
- Process design
- Action
- The recalling firm issued a letter dated 7/10/2018 to their field representatives (agencies) via email explaining the reason for recall.
- Quantity
- 28 (14 REF S200635 and 14 S200636)
- Distribution
- Distribution was made to CA, CO, MD, MN, OH, TX, and WA. There was no foreign/military/government distribution.
- Lot, serial or model codes
- All Revision C trials. REF S-2000635: 313R1000, 313R1900, 313R1901; REF S-200636: 314R1000, 314R1900, 314R1901.
- 510(k) numbers
- ["K120241"]
- PMA numbers
- not on file
- Product code
- LPH
- 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