| Class 2 Device Recall Conformer Large (sterile) | |
Date Initiated by Firm | November 29, 2002 |
Date Posted | February 05, 2003 |
Recall Status1 |
Terminated 3 on February 06, 2004 |
Recall Number | Z-0536-03 |
Recall Event ID |
25123 |
510(K)Number | K972661 |
Product Classification |
Implant, Orbital, Extra-Ocular - Product Code HQX
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Product | Conformer - Large (Sterile) |
Code Information |
model number 14166. lot number 1218 |
Recalling Firm/ Manufacturer |
Gulden Ophthalmics 225 Cadwalader Ave Elkins Park PA 19027-2020
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For Additional Information Contact | Thomas D. Cockley 215-884-8105 |
Manufacturer Reason for Recall | lack of sterility assurance |
FDA Determined Cause 2 | Other |
Action | The recalling firm issued letters to the accounts requesting the return of the devices. |
Distribution | Nationwide (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 Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = HQX
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