Recall Z-1093-2015 ยท FTL Mesh, Surgical, Polymeric
Stryker Craniomaxillofacial Division
MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right 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 contou
| Date | Feb 11, 2015 (initiated Dec 17, 2014) |
| Status | Terminated |
| Reason | Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW - MTB - Left. The appropriate articles were actually included in the shipment. However, the products had an incorrect barrier location. |
| Root 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040364 | MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH Porex Surgical, Inc., Jun 30, 2004 |