Recall Z-1650-2012 ยท ISH Component, External, Limb, Ankle/Foot
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.
| Date | May 23, 2012 (initiated Apr 5, 2012) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.