Stryker Craniomaxillofacial Division

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-0114-2016Class IIDisposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F,September 17, 2015
Z-1090-2015Class IIMEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A140December 17, 2014
Z-1091-2015Class IIMEDPOR BARRIER Sheets Orbital Floor Implant Product Usage: MEDPOR Implants in block, sheet and December 17, 2014
Z-1093-2015Class IIMEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right Product Usage: December 17, 2014
Z-1092-2015Class IIMEDPOR BARRIER Sheets Rectangle Product Usage: MEDPOR Implants in block, sheet and pre-formed shDecember 17, 2014
Z-2054-2013Class IIStryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3ccJuly 30, 2013