ModerateClass IITerminated

FDA Devices recall · Reported February 18, 2015

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.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1093-2015.

Q: Where was the recalled product distributed?

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..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 s…

Recall #: Z-1093-2015
Affected scope: 1051
Initiated: December 17, 2014

Compiled from official public sources by the publisher. · Updated September 2026

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Stryker Craniomaxillofacial Division recalled MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Prod… - a moderate-severity action.

MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Prod… was recalled by Stryker Craniomaxillofacial Division in February 18, 2015. Reason: Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW …. Check the official notice for the remedy. Verify recall #Z-1093-2015 with the FDA Devices before acting.

The recall

Stryker Craniomaxillofacial Division issued this moderate-severity FDA Devices recall-Article #81036 (MEDPOR Titan Max OFW - MTB - Right) reportedly contained article #81035 MEDPOR Titan Max OFW ….

Moderate
severity level: 1K units
affected scope: Class II
classification: February 18, 2015
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-1093-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-1093-2015) was formally reported on February 18, 2015, with the manufacturer initiating the action on December 17, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Craniomaxillofacial Division is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 1051.

The documented reason for this recall is: 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 in… Distribution data in the federal record shows the product reached: 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: Ar…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-1093-2015
Date reported	February 18, 2015
Date initiated	December 17, 2014
Recalling firm	Stryker Craniomaxillofacial Division
Firm location	Portage, MI
Affected scope	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, …

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

1051 units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-1093-2015) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on February 18, 2015. Severity: Moderate. Recall number: Z-1093-2015.

Where was the recalled product distributed? ▼

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..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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This recall: FDA Devices, reported February 18, 2015. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026