FDADecember 17, 2014device

MEDPOR BARRIER Sheets Orbital Floor Implant 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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

stryker craniomaxillofacial divisionstrykerstryker craniomaxillofacial

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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