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U.S. Department of Health and Human Services

Class 2 Device Recall MEDPOR PLUS

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  Class 2 Device Recall MEDPOR PLUS see related information
Date Initiated by Firm March 20, 2012
Date Posted April 18, 2012
Recall Status1 Terminated 3 on August 10, 2012
Recall Number Z-1435-2012
Recall Event ID 61620
510(K)Number K021357  
Product Classification Implant, eye sphere - Product Code HPZ
Product MEDPOR PLUS SST EZ 22mm Sphere Implant, Howmedica Osteonics Corp, 15 Dart Road, Newnan, GA 30265. MEDPOR PLUS Orbital Implants are intended to restore the volume of an enucleated or eviscerated eye globe.
Code Information Catalog number: 80062, Lot Codes: F000689 and G004528.
Recalling Firm/
Manufacturer		 Howmedica Osteonics Corp dba Stryker Craniomaxillofacial
15 Dart Rd
Newnan GA 30265-1017
For Additional Information Contact Stephanie Fullard
678-479-1610 Ext. 602
Manufacturer Reason
for Recall		 The MEDPOR PLUS SST EZ 22mm sphere implants are not within specification of 22mm +/- 8, therefore implant is not easily released from the syringe.
FDA Determined
Cause 2		 Process control
Action The sole distributor was notified by "Urgent Product Recall" letter on March 20, 2012. "Urgent Medical Device Recall" letters were sent to Stryker Customers on March 26, 2012. The letters described the product issue, hazards, and actions recommended to mitigate the risk. Customer number provided: (800) 962-6558.
Quantity in Commerce 31 units
Distribution US Distribution, the state of Michigan.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = HPZ and Original Applicant = POREX SURGICAL, INC.
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