Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1091-2015 — 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 Implan

U.S. FDA — Device Enforcement · United States · 2014-12-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1091-2015
Date of alert: 2014-12-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Stryker Craniomaxillofacial Division
Product category: device
Product type: Devices

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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