MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR… — Class II medical device recall Z-1091-2015
Terminated recall by Stryker Craniomaxillofacial Division, reported 2015-02-18, distributed nationwide. Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operat
| Recall number | Z-1091-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Craniomaxillofacial Division, Portage, MI, United States |
| Recall initiated | 2014-12-17 |
| Classified | 2015-02-11 |
| Reported by FDA | 2015-02-18 |
| Terminated | 2015-11-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, CH, CL, CN, CO, ES, FR, KR, NL, SG, ZA |
| Quantity | 1,051 |
| Reason classes | specification failure, packaging |
| Lot numbers | 69698, 77004, 81799, A1310051, A1311008, A1311044, A1312011, A1402023, A1404010 |
| Model numbers | 9305 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1091-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.