CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report

Medpor Titan Max Orbital Floor and Wall recalled

Stryker Craniomaxillofacial Division is recalling Medpor Titan Max Orbital Floor and Wall (Ofw) Medpor-Titanium-Barrier (Mtb) Right, distributed nationwide in the US. The recall was initiated on 17 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart Number 81036; Lot Number A1402020, A1405060
Quantity recalled1051

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-1093-2015
FDA event ID
70166
Recalling firm
Stryker Craniomaxillofacial Division, Portage, MI
Classification
Class II
Status
Terminated
Recall initiated
17 Dec 2014
FDA classified
11 Feb 2015
Reported
18 Feb 2015
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Other Reasons

Timeline

17 Dec 2014Recall initiated by company
11 Feb 2015Classified by FDA+56 days
18 Feb 2015Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide AlabamaArkansasCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Part Number 81036; Lot Number A1402020, A1405060

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

3 other products · FDA event 70166

This product is part of a recall event; the main page for the event is Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial.

ReportedClassRecallCompanyReasonWhere
CLASS IIMedpor Barrier Sheets Rectangle recalled by Stryker CraniomaxillofacialStryker Craniomaxillofacial DivisionPotency & AssayNationwide
CLASS IIMedpor Barrier Sheets Orbital Floor Implant recalledStryker Craniomaxillofacial DivisionPotency & AssayNationwide
CLASS IIMedpor Surgical Implant Contoured Two Piece Chin recalledStryker Craniomaxillofacial DivisionDevice MalfunctionNationwide

More recalls from Stryker Craniomaxillofacial Division

All 6
ReportedClassRecallCompanyReasonWhere
DeviceCLASS IIDisposable Paper, Medical Accessory, 100 DISP, Paper F recalledStryker Craniomaxillofacial DivisionSterilityMI
DeviceCLASS IIMedpor Surgical Implant Contoured Two Piece Chin recalledStryker Craniomaxillofacial DivisionDevice MalfunctionNationwide
DeviceCLASS IIMedpor Barrier Sheets Orbital Floor Implant recalledStryker Craniomaxillofacial DivisionPotency & AssayNationwide
DeviceCLASS IIMedpor Barrier Sheets Rectangle recalled by Stryker CraniomaxillofacialStryker Craniomaxillofacial DivisionPotency & AssayNationwide
DeviceCLASS IIStryker Part Numbers 79-43903 (3cc), 79-43905 (5cc) recalledStryker Craniomaxillofacial DivisionPackaging DefectsNationwide

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