CLASS II Device recall · Reported 18 Feb 2015 · FDA Enforcement Report
Medpor Surgical Implant Contoured Two Piece Chin recalled
Stryker Craniomaxillofacial Division is recalling Medpor Surgical Implant Contoured Two Piece Chin, distributed nationwide in the US. The recall was initiated on 17 Dec 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1090-2015
- FDA event ID
- 70166
- Recalling firm
- Stryker Craniomaxillofacial Division, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Dec 2014
- FDA classified
- 11 Feb 2015
- Reported
- 18 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 17 Dec 2014 | Recall initiated by company | |
| 11 Feb 2015 | Classified by FDA | +56 days |
| 18 Feb 2015 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential for implant damage, implant cracking off/breaking intra-operatively.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026 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.
Where it was distributed
Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.
Nationwide AlabamaArkansasCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMichiganMinnesotaMissouri
Questions about this recall
Why was it recalled?
Potential for implant damage, implant cracking off/breaking intra-operatively.
Which lots are affected?
Part Number 86001; Lot Numbers A1405048, A1404026
Where was it sold?
Worldwide Distribution - US Nationwide in the states of PA, KY, VA, CT, UT, MD, AR, FL, TX, AL, DE, IL, IA, MI, CO, OH, GA, CA, DC, MO, LA, WI, ID, SC, NC, NY, MA, NH, CA, OK, MN, KY, IN, OR, TN and the countries of: Argentina, Australia, Canada, Chile, China, Netherlands, France, Spain, South Korea, Colombia, Switzerland, Singapore, and South Africa.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 70166This product is part of a recall event; the main page for the event is Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial | Stryker Craniomaxillofacial Division | Potency & Assay | Nationwide | |
| CLASS II | Medpor Barrier Sheets Orbital Floor Implant recalled | Stryker Craniomaxillofacial Division | Potency & Assay | Nationwide | |
| CLASS II | Medpor Titan Max Orbital Floor and Wall recalled | Stryker Craniomaxillofacial Division | Other | Nationwide |
More recalls from Stryker Craniomaxillofacial Division
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Disposable Paper, Medical Accessory, 100 DISP, Paper F recalled | Stryker Craniomaxillofacial Division | Sterility | MI |
| Device | CLASS II | Medpor Titan Max Orbital Floor and Wall recalled | Stryker Craniomaxillofacial Division | Other | Nationwide |
| Device | CLASS II | Medpor Barrier Sheets Orbital Floor Implant recalled | Stryker Craniomaxillofacial Division | Potency & Assay | Nationwide |
| Device | CLASS II | Medpor Barrier Sheets Rectangle recalled by Stryker Craniomaxillofacial | Stryker Craniomaxillofacial Division | Potency & Assay | Nationwide |
| Device | CLASS II | Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc) recalled | Stryker Craniomaxillofacial Division | Packaging Defects | Nationwide |
Other Surgical Instruments recalls
All 3,809| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: IV Start KIT recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Packaging Defects | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled | ConMed | Other | Nationwide |