The Recall Desk
SevereFDA (Devices)·Z-1092-2015·Announced 2015-02-18

Stryker Recalls MEDPOR BARRIER Sheets Due to Deformation and Cracking Risks

Stryker is recalling MEDPOR BARRIER Sheets due to potential implant deformation, mechanical instability, and cracking during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (deformation, cracking, mechanical instability) in a medical implant, which aligns with the rubric criteria for 'Severe' severity involving structural defects or significant injury risks.

Plain-English summary

Stryker Craniomaxillofacial Division is recalling MEDPOR BARRIER Sheets, Rectangle, Part Number 9312, Lot Number A1403008. The recall involves 1,051 units that were distributed worldwide, including nationwide in the United States and in several international countries.

The recall was initiated because of a potential for implant deformation, insufficient mechanical stability, loss of barrier adhesion during surgery, implant damage, and cracking or breaking of the implant intra-operatively. These implants are intended for non-weight-bearing applications in craniofacial reconstruction, cosmetic surgery, and repair of craniofacial trauma.

Healthcare providers and patients who have received these specific implants should contact Stryker Craniomaxillofacial Division for further instructions regarding the recall and potential replacement or removal of the devices.

The recalled product

Product
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
Manufacturer
Stryker Craniomaxillofacial Division
Category
Medical Device — Surgical Implants
Hazard
Affected units
1,051

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Part Number 9312
  • Lot Number A1403008

Distribution

Distributed nationwide across the United States.

The notice also names 33 states specifically:

Part of a larger recall action

This product is one of 4 recalled by Stryker Craniomaxillofacial Division under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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