Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.

FDA Recall Z-1650-2012 · Posted 2012-05-23

Recalling FirmCollege Park Industries, Inc.
Recall StatusTerminated
Product CodeISH
Date Initiated2012-04-05
Date Terminated2012-07-31
Product Quantity11

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.

Firm 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, [email protected].

Root Cause

Mixed-up of materials/components

Distribution Pattern

Worldwide Distribution - USA, including the states of CA, MA, ME, WA, TX, VA, AZ and the country of England.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑