Reported Feb 18, 2015 · Terminated
MEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are…
Stryker Craniomaxillofacial Division
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Stryker Craniomaxillofacial Division · 750 Trade Centre Way · Portage, MI · 49002-0482
Is this the product you have?
- MEDPOR BARRIER Sheets
- Orbital Floor Implant Product UsageMEDPOR 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
- Lot codes and dates
Part Number 9305Lot Numbers 696987700481799A1310051A1311008A1311044A1312011A1402023A1404010
- Amount recalled
- 1051
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Potential for implant deformation, implant mechanical stability too low, loss of barrier adhesion intra-operatively, implant damage, implant cracking off/breaking intra-operatively.
This product could cause temporary or reversible health problems — stop using it.
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