Product is packed in a pouch which is labeled as MicroChoice FOOTSWITCH Linvatec LINVATEC CORPORATION LARGO, FL 33773 US
FDA device recall Z-0717-03 · posted 2003-04-10 · Terminated
Recall details
- Recalling firm
- Linvatec Corp DBA Linvatec/Hal
- Reason for recall
- The Footswitch functions of the left and right foot pedals may be reversed in some units.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- HWE
- Quantity affected
- 74
- Distribution
- Nationwide, worldwide.
- Date initiated
- 2003-01-24
- Date posted
- 2003-04-10
- Date terminated
- 2012-07-07
- Location
- Largo, FL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HALL MICROCHOICE ELECTRIC POWERED SYSTEM (K942660) | Hall Surgical, Division of Zimmer, Inc. | 1994-09-07 |