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Z-1092-2015 Class II Terminated

Recalled by Stryker Craniomaxillofacial Division — Portage, MI

FDA device recall Z-1092-2015 was initiated by Stryker Craniomaxillofacial Division on December 17, 2014 and is designated Class II. Reason for recall: Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively. The recall status is terminated (terminated November 6, 2015). Affected quantity: 1051.

Recall Details

Product Type: Devices
Report Date: February 18, 2015
Initiation Date: December 17, 2014
Termination Date: November 6, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1051

Product Description

MEDPOR BARRIER Sheets Rectangle 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

Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.

Distribution Pattern

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.

Code Information

Part Number 9312; Lot Number A1403008

Other recalls by Stryker Craniomaxillofacial Division

Z-0114-2016 Class II — Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory (September 17, 2015)
Z-1090-2015 Class II — MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Nu (December 17, 2014)
Z-1091-2015 Class II — MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants (December 17, 2014)
Z-1093-2015 Class II — MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Righ (December 17, 2014)
Z-2054-2013 Class II — Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (July 30, 2013)