FDA Medical Device Recalls (openFDA)
Encore Medical, Lp: MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
- Recall number
- Z-2242-2016
- Recalling firm
- Encore Medical, Lp
- Product
- MODIFIED LINEAR STANDARD/LATERAL NECK TRIALS WITH SPRING SIDES REF S-200635 and S-200636
- Status
- Terminated
- Initiated
- 2016-06-21
- Posted
- 2016-07-19
- Terminated
- 2017-01-10
- Reason
- Reported failure of the instrument. The retaining ring component of a neck trial became disassembled from the body of the neck.
- Root cause
- Process design
- Action
- The recalling firm notified affected consignees via letter on 6/21/16. The consignees were instructed to return the affected devices.
- Quantity
- 14 (7 sets)
- Distribution
- CO, ID, TX
- Lot, serial or model codes
- Lot: 313R1000, 313R1900, 313R1901, 314R1000, 314R1900, 314R1901
- 510(k) numbers
- ["K974294"]
- 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