MEDPOR TITAN MAX Orbital Floor and Wall (OFW)… recallZ-1093-2015 · Stryker Craniomaxillofacial Division · initiated Dec 17, 2014
Class II Terminated All recalls posted in February 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Craniomaxillofacial Division or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was 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.
FDA root cause category: Process control
What the company is doing
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 [email protected].
Recall details
- Recall number
- Z-1093-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Dec 17, 2014
- Posted by the FDA
- Feb 11, 2015
- Recalling firm
- Stryker Craniomaxillofacial Division
- Quantity
- 1051
- Product code
- FTL
- FDA submissions
- K040364
- 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.
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.
Code information (models, lots, serial numbers)
Part Number 81036; Lot Number A1402020, A1405060
Other devices under the same FDA submission
4 devices cleared under K040364 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- MEDPOR TITAN 81032Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 recall1 report
- MEDPOR TITAN 81033Stryker Leibinger GmbH & Co. KG · Mesh, surgical2 reports
- MEDPOR TITAN 81024Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 report
- MEDPOR TITAN 81029Stryker Leibinger GmbH & Co. KG · Mesh, surgical1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 70166).
- Z-1090-2015 · TerminatedMEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are i…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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