FDA Device 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-weigh…
- FDA Device
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weigh… by Stryker Craniomaxillofacial Division, citing potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1091-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-17 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Stryker Craniomaxillofacial Division |
| Distribution | US |
Product
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 are intended for the augmentation or restoration of bony contour in the craniofacial skeleton.
Reason
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
Identifiers
| code_info | Part Number 9305; Lot Numbers 69698, 77004, 81799, A1310051, A1311008, A1311044, A1312011, A1402023, A1404010 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1091-2015%22
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