Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.
This recall has been terminated (originally issued May 23, 2012).
- Company
- College Park Industries, Inc.
- Recall Initiated
- April 5, 2012
- Posted
- May 23, 2012
- Terminated
- July 31, 2012
- Recall Number
- Z-1650-2012
- Quantity
- 11
- Firm Location
- Fraser, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Worldwide Distribution - USA, including the states of CA, MA, ME, WA, TX, VA, AZ and the country of England.
Lot / Code Info
Product Number103658-00, Lot/ Serial Number (USA)TE012171, TE012151, TE012142, TE012159, TE012158, TE012154, TE012186, TE012185, TE012161, TE012139, (UK)TE012182.
Root Cause
Mixed-up of materials/components
Action Taken
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.