FDA Medical Device Recalls (openFDA)
College Park Industries, Inc.: Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.
- Recall number
- Z-1650-2012
- Recalling firm
- College Park Industries, Inc.
- Product
- Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.
- Status
- Terminated
- Initiated
- 2012-04-05
- Posted
- 2012-05-23
- Terminated
- 2012-07-31
- Reason
- An incorrect shorter part ( pyramid) was installed in the foot. A foot of this size and configuration requires a longer pyramid. Customers requiring the extra firm configuration may have a minimal risk of component failure, which could be implicated in a potential fall.
- Root cause
- Mixed-up of materials/components
- Action
- All customers who received affected product were initially contacted via phone on April 5, 2012 and made aware of the recall, including instructions to notify customers immediately and arrange replacements. A "Recall Notice" letter dated April 24, 2012 was sent to customers describing the problem and the recommended actions. Contact reference person is Kimberly Light, 1 800-728-7950, info@college-park.com.
- Quantity
- 11
- Distribution
- Worldwide Distribution - USA, including the states of CA, MA, ME, WA, TX, VA, AZ and the country of England.
- Lot, serial or model codes
- Product Number103658-00, Lot/ Serial Number (USA)TE012171, TE012151, TE012142, TE012159, TE012158, TE012154, TE012186, TE012185, TE012161, TE012139, (UK)TE012182.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ISH
- Firm FEI
- 1000220701
- Firm city
- Fraser
- Firm state
- MI
- 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