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U.S. Department of Health and Human Services

Class 2 Device Recall MEDPOR BARRIER Sheets Rectangle

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  Class 2 Device Recall MEDPOR BARRIER Sheets Rectangle see related information
Date Initiated by Firm December 17, 2014
Date Posted February 11, 2015
Recall Status1 Terminated 3 on November 06, 2015
Recall Number Z-1092-2015
Recall Event ID 70166
510(K)Number K952677  
Product Classification Prosthesis, chin, internal - Product Code FWP
Product MEDPOR BARRIER Sheets Rectangle

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 9312; Lot Number A1403008
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 deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
FDA Determined
Cause 2		 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 and Original Applicant = POREX SURGICAL, INC.
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