FDA Medical Device Recalls (openFDA)
Med Tec Inc: Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
- Recall number
- Z-1721-2009
- Recalling firm
- Med Tec Inc
- Product
- Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion.
- Status
- Terminated
- Initiated
- 2009-03-06
- Posted
- 2009-08-20
- Terminated
- 2009-11-05
- Reason
- The silkscreened indexing scale was reversed.
- Root cause
- Error in labeling
- Action
- Med Tec inc. (CIVCO Medical Solutions, Radiation Oncology) issued a "Recall Notification" notice dated March 6, 2009 via certified mail explaining the reason for recall and providing the customer a choice of returning the product for replacement or not take any action. A response form was enclosed to be returned via FAX to indicate the number of units in their possession and whether or not they are being returned. Telephone calls were initiated April 20, 2009 to nonresponders or for any consignee whose letter was returned as undeliverable. Foreign customers were notified by e-mail or phone beginning March 16, 2009. For further information, contact CIVCO Medical Solutions, Radiation Oncology at 1-800-842-8688.
- Quantity
- 231 units
- Distribution
- Worldwide Distribution -- Including the United States, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan.
- Lot, serial or model codes
- Lot NNumbers: M055260, M042340, M024020, M022010 and M006980
- 510(k) numbers
- K973842
- PMA numbers
- not on file
- Product code
- IXQ
- Firm FEI
- 1000143606
- Firm city
- Orange City
- Firm state
- IA
- 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