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U.S. Department of Health and Human Services

Class 2 Device Recall Celsus Foot

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  Class 2 Device Recall Celsus Foot see related information
Date Initiated by Firm April 05, 2012
Date Posted May 23, 2012
Recall Status1 Terminated 3 on July 31, 2012
Recall Number Z-1650-2012
Recall Event ID 61701
Product Classification Component, external, limb, ankle/foot - Product Code ISH
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.
Code Information Product Number103658-00, Lot/ Serial Number (USA)TE012171, TE012151, TE012142, TE012159, TE012158, TE012154, TE012186, TE012185, TE012161, TE012139, (UK)TE012182.
Recalling Firm/
Manufacturer		 College Park Industries, Inc.
17505 Helro
Fraser MI 48026-2226
For Additional Information Contact Kimberly Light
810-294-7950
Manufacturer 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 Determined
Cause 2		 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 in Commerce 11
Distribution Worldwide Distribution - USA, including the states of CA, MA, ME, WA, TX, VA, AZ and the country of England.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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