Recall Z-0717-03 ยท HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
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
| Date | Apr 10, 2003 (initiated Jan 24, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942660 | HALL MICROCHOICE ELECTRIC POWERED SYSTEM Hall Surgical, Division of Zimmer, Inc., Sep 7, 1994 |