Class 2 Device Recall MEDPOR PLUS

• Date Initiated by Firm: March 20, 2012
• Date Posted: April 18, 2012
• Recall Status: Terminated 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: 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