MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: MEDPOR Implants in bloc
FDA device recall Z-1093-2015 · posted 2015-02-11 · Terminated
Recall details
- Recalling firm
- Stryker Craniomaxillofacial Division
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 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 t
- Date initiated
- 2014-12-17
- Date posted
- 2015-02-11
- Date terminated
- 2015-11-06
- Location
- Portage, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH (K040364) | Porex Surgical, Inc. | 2004-06-30 |