Recall Z-1093-2015— Stryker Craniomaxillofacial Division

Name: FDA recall Z-1093-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-17

Class II · Terminated

Class II FDA medical device recall by Stryker Craniomaxillofacial Division, initiated 2014-12-17, terminated 2015-11-06. It names one FDA 510(k) clearance: K040364. Product: 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 contour in the craniofacial skeleton.. 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..

Recalling firm: Stryker Craniomaxillofacial Division
Classification: Class II
Status: Terminated
Initiated: 2014-12-17
Terminated: 2015-11-06
Firm location: Portage, MI, United States

510(k) clearances named in this recall

1 on FDA's record

K040364 — MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESHPorex Surgical, Inc.·cleared 2004-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 contour in the craniofacial skeleton.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.