Class 2 Device Recall MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm

• Date Initiated by Firm: December 17, 2014
• Date Posted: February 11, 2015
• Recall Status: Terminated on November 06, 2015
• Recall Number: Z-1090-2015
• Recall Event ID: 70166
• 510(K)Number: K922489
• Product Classification: Prosthesis, chin, internal - Product Code FWP
• Product: MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. MEDPOR Surgical Implants and MEDPOR BARRIER Implants are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
• Code Information: Part Number 86001; Lot Numbers A1405048, A1404026
• Recalling Firm/ Manufacturer: Stryker Craniomaxillofacial Division; 750 Trade Centre Way; Ste 200; Portage MI 49002-0482
• For Additional Information Contact: Nathan Vansweden; 269-389-6211
• Manufacturer Reason for Recall: Potential for implant damage, implant cracking off/breaking intra-operatively.
• FDA Determined Cause: Process control
• Action: Stryker sent an Urgent Medical Device Recall Notice dated December 23, 2014, to all affected customers with a response form to be completed and returned upon receipt and review. The letter identified the affected product, potential hazards, risk mitigation and the actions to be taken. For questions contact Stryker CMF at 1-800-962-6558, or e-mail at CMF-custserv@stryker.com.
• Quantity in Commerce: 1051
• Distribution: Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.
• 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 = FWP