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U.S. Department of Health and Human Services

Class 2 Device Recall Conformer Large (sterile)

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 Class 2 Device Recall Conformer Large (sterile)see related information
Date Initiated by FirmNovember 29, 2002
Date PostedFebruary 05, 2003
Recall Status1 Terminated 3 on February 06, 2004
Recall NumberZ-0536-03
Recall Event ID 25123
510(K)NumberK972661 
Product Classification Implant, Orbital, Extra-Ocular - Product Code HQX
ProductConformer - Large (Sterile)
Code Information model number 14166. lot number 1218
Recalling Firm/
Manufacturer
Gulden Ophthalmics
225 Cadwalader Ave
Elkins Park PA 19027-2020
For Additional Information ContactThomas D. Cockley
215-884-8105
Manufacturer Reason
for Recall
lack of sterility assurance
FDA Determined
Cause 2
Other
ActionThe recalling firm issued letters to the accounts requesting the return of the devices.
DistributionNationwide (The devices were shipped to distributors and hospitals in PA, MO, OH, LA, LA, NY, NJ, NC, IA, CA, MA, VT, TX ) and New Zealand
Total Product Life CycleTPLC Device Report

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.
510(K) Database510(K)s with Product Code = HQX
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