FDA Medical Device Recalls (openFDA)
Linvatec Corp DBA Linvatec/Hal: Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
- Recall number
- Z-0717-03
- Recalling firm
- Linvatec Corp DBA Linvatec/Hal
- Product
- Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 USA 5020-053
- Status
- Terminated
- Initiated
- 2003-01-24
- Posted
- 2003-04-10
- Terminated
- 2012-07-07
- Reason
- The Footswitch functions of the left and right foot pedals may be reversed in some units.
- Root cause
- Other
- Action
- The firm telephoned and mailed a Recall Notification letter with response form to all Accounts beginning on 1/24/03. Distributors were asked to subrecall down to the medical facility level. Recalled devices are to be returned to Linvatec for testing.
- Quantity
- 74
- Distribution
- Nationwide, worldwide.
- Lot, serial or model codes
- Units under recall include the following serial numbers: 3582 thru 3681, 3685 thru 3733, 3739 thru 3766, 3768, 3800 thru 3809 (74 units)
- 510(k) numbers
- ["K942660"]
- PMA numbers
- not on file
- Product code
- HWE
- Firm FEI
- 1017294
- Firm city
- Largo
- Firm state
- FL
- 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