Reported Feb 18, 2015 · Terminated
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 Product Usage:…
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 Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048
- A1404026 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 86001Lot Numbers A1405048A1404026
- 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 damage, implant cracking off/breaking intra-operatively.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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