Z-1650-2012

Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb...

Name: Z-1650-2012 Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb...
Creator: College Park Industries, Inc.
Published: 2012-04-05
License: https://open.fda.gov/license/

College Park Industries / initiated 2012-04-05 / Terminated

FDA source

College Park Industries, Inc. began a recall of Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs on 2012-04-05. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1650-2012
Status: Terminated
Initiated: 2012-04-05
Posted: 2012-05-23
Terminated: 2012-07-31
Recalling firm: College Park Industries
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.
Product code: ISH Component, External, Limb, Ankle/Foot
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.
FDA 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, [email protected].
Quantity in commerce: 11
Distribution: Worldwide Distribution - USA, including the states of CA, MA, ME, WA, TX, VA, AZ and the country of England.
Product codes and lots: Product Number103658-00, Lot/ Serial Number (USA)TE012171, TE012151, TE012142, TE012159, TE012158, TE012154, TE012186, TE012185, TE012161, TE012139, (UK)TE012182.

Product code ISH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)