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Class 2 Device Recall Conformer Medium (sterile) |
 |
| Date Initiated by Firm |
November 29, 2002 |
| Date Posted |
February 05, 2003 |
| Recall Status1 |
Terminated 3 on February 06, 2004 |
| Recall Number |
Z-0535-03 |
| Recall Event ID |
25123 |
| 510(K)Number |
K972661
|
| Product Classification |
Implant, Orbital, Extra-Ocular - Product Code HQX
|
| Product |
Conformer - Medium (Sterile) |
| Code Information |
model number 14165. lot number 1187 |
Recalling Firm/
Manufacturer |
Gulden Ophthalmics
225 Cadwalader Ave
Elkins Park PA 19027-2020
|
| 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 and Original Applicant = GULDEN OPHTHALMICS
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